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Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimavanserin
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is able to understand and provide signed informed consent
  2. Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scale
  3. Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study ACP-103-038 or 064 while continuing to take his/her assigned dose of blinded study drug and may, in the Investigator's opinion, benefit from continued adjunctive treatment with pimavanserin to a antipsychotic
  4. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception
  5. The main background antipsychotic with which the subject is being treated must continue to be on one of the antipsychotics listed below:

    • Aripiprazole
    • Aripiprazole long-acting injectables:

      • Abilify Maintena®
      • Aristada®
    • Asenapine
    • Risperidone
    • Risperidone long-acting injection
    • Olanzapine
    • Paliperidone extended release (ER) (≤9 mg)
    • Paliperidone palmitate

      • Invega Sustenna® (≤156 mg)
      • Invega Trinza® (≤546 mg)
      • Trevicta® (≤350 mg)
      • Xeplion® (≤100 mg)
    • Lurasidone
    • Cariprazine
    • Brexpiprazole
    • Asenapine

Exclusion Criteria:

  1. Patient is judged by the Investigator or the Medical Monitor to be inappropriate for the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -064)
  2. A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse

    1. Subjects from Studies 034 and 038 with a result indicating the presence of marijuana are permitted, if allowed by medical regulations, if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation
    2. Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study
  3. Is taking a medication or drug or other substance that is prohibited according to this protocol
  4. Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval
  5. Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study.

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

Sites / Locations

  • 171-Alea Research Institute
  • 156-Woodland International Research Group, LLC
  • 111-Woodland Research Northwest, LLC
  • 154-Advanced Research Center, Inc.
  • 167-CITrials - Bellflower
  • 147-Comprehensive Clinical Development
  • 105-ProScience Research Group
  • 121-Behavioral Research Specialists, LLC
  • 123-Synergy San Diego
  • 150-Apostle Clinical Trials, Inc.
  • 126-Long Beach VA Healthcare System
  • 120-Pacific Institute of Medical Research
  • 107-Pacific Research Partners, LLC
  • 164-Artemis Institute for Clinical Research
  • 122-Sharp Mesa Vista Hospital
  • 165-CITrials
  • 108-Collaborative Nueroscience Network, LLC
  • 112-Flagship Norwalk, LLC
  • 158-Charles E. Schmidt College of Medicine Florida Atlantic University
  • 119-Meridien Research
  • 125-Galiz Research
  • 132-Clinical Neuroscience Solutions Inc.
  • 137-Innovative Clinical Research, Inc.
  • 146-Premier Clinical Research Institute, Inc.
  • 149-Miller School of Medicine University of Miami
  • 166-Meridien Research
  • 163-Stedman Clinical Trials
  • 162-Synexus Clinical Research, Inc.
  • 168-Atlanta Center for Medical Research
  • 135-Georgia Regents University, Department of Psychiatry & Behavioral Health
  • 152-iResearch Atlanta LLC
  • 102-Northwest Behavioral Research Center
  • 114-Northwestern University
  • 101-American Medical Research
  • 130-Alexian Brothers Center for Psychiatric Research
  • 133-Department of Psychiatry and Behavioral Sciences KU School of Medicine-Wichita - 133
  • 118-Lake Charles Clinical Trials
  • 116-Louisiana Clinical Research Center
  • 157-Maryland Psychiatric Research Center
  • 151-Michigan Clinical Research Institute PC
  • 134-Precise Research Centers
  • 113-St. Charles Psychiatric Associates Midwest Research Group
  • 148-Washington University School of Medicine St. Louis
  • 109-St. Louis Clinical Trials, LLC
  • 143-Premier Psychiatric Research Institute, LLC
  • 124-Altea Research Institute
  • 141-Hassman Research Institute
  • 169-PRA Health Sciences
  • 153-Albuquerque Neuroscience Inc.
  • 104-Neurobehavioral Research, Inc.
  • 140-Synexus Clinical Research, Inc - 140
  • 128-Finger Lakes Clinical Research
  • 106-New Hope Clinical Research
  • 145-Carolina Behavioral Care
  • 139-University Hospitals Cleveland Medical Center
  • 138-Midwest Clinical Research Center
  • 129-Insight Clinical Trials, LLC
  • 110-Cutting Edge Research Group
  • 170-Suburban Research Associates
  • 144-Carolina Clinical Trials, Inc.
  • 155-Bayou City Research, Ltd.
  • 127-University Hills Clinical Research
  • 103-Pillar Clinical Research, LLC
  • 115-Psychiatric and Behavioral Solutions LLC
  • 610-Clinica Privada Banfield S.A.
  • 603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEMRecruiting
  • 625-NOVAIN Neurociencias Group
  • 601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRLRecruiting
  • 602-FunDamoSRecruiting
  • 607-Resolution Psicopharmacology Research InstituteRecruiting
  • 626-Sanatorio Prof. Leon S. Morra S.A.
  • 622-Instituto Medico Damic Srl
  • 624-Centro Especializado en Neurociencias CEN
  • 617-INSA Instituto de Neurociencias San Agustin S.A.Recruiting
  • 623-Clinica Privada de Salud Mental Santa Teresa de Avila
  • 454-Mental Health Centre 'Prof. Dr. Ivan Temkov', EOODRecruiting
  • 533-State Psychiatric Hospital - Kardzhali, EOODRecruiting
  • 532-MHAT "Dr. Hristo Stambolski", EOODRecruiting
  • 569-State Psychiatric Hospital - LovechRecruiting
  • 406-State Psychiatric Hospital - Pazardzhik AD
  • 535-UMHAT 'Dr. Georgi Stranski', EADRecruiting
  • 586-Medical Center Mentalcare OODRecruiting
  • 563-MC-Hipokrat-N E00D
  • 403-University Multiprofile hospital for activated treatment Sveti Georgi, Clinic of psychiatry
  • 592-Medical center Spectar - Plovdiv EOODRecruiting
  • 570-Medical Centre "Sveti Naum"Recruiting
  • 497-MHC - Sofia, EOOD
  • 526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OODRecruiting
  • 402-Military Medical Academy, Multiprofile Hospital for Actie Treatment - Sofia
  • 405-UMHAT "Alexandrovska" EADRecruiting
  • 568-Medical Center Hera EOODRecruiting
  • 528-Medical Center Intermedica, OODRecruiting
  • 404-MHAT-Targovishte, AD
  • 590-State Psychiatric Hospital - Tzarev Brod
  • 407-State Psychiatric Hospital - Tserova Koria
  • 498-DCC "Mladost M" - Varna, OODRecruiting
  • 455-Mental Health Center - Veliko Tarnovo EOODRecruiting
  • 401-Mental Health Center-Vratsa EOODRecruiting
  • Dr. Alexander McIntyre Inc.
  • Chatham-Kent Clinical Trials Research Ctr
  • 352 - Centre for Addiction and Mental Health
  • 351-McGill University Health Ctr Allan Memorial Int.
  • 356-Chatham-Kent Clinical Trials Research Ctr
  • 354-Queens University at Kingston, Providence Care Hospital
  • 355-Sunny Johnson Medical Research Associates
  • 357-Dr. Alexander McIntyre Inc.
  • 536 - Clinic for psychiatry Vrapce
  • 537 - Clinic for psychiatry VrapceRecruiting
  • 550-Clinic for psychiatry Vrapce
  • 557 - Clinic for psychiatry VrapceRecruiting
  • 594-Klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika
  • 512-NeuropsychiatrieHK s.r.o.Recruiting
  • 583-Narodni ustav dusevniho zdraviRecruiting
  • 519-A-SHINE s.r.o.Recruiting
  • 513-CLINTRIAL s.r.o.
  • 499-MUDr. Tibor Miklos
  • 491-MEDICAL SERVICES PRAGUE s.r.o.
  • 511-Psychiatrie Ricany s.r.o.
  • 410-Dr. Máthé és Társa Bt.Recruiting
  • 411-ÓBudai Egészségűgyi Centrum Kft
  • 456-Semmelweis University Department of Psychiatry and PsychotherapyRecruiting
  • 521-Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont
  • 520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
  • 527-Debreceni Egyetem
  • 412-Békés Megyei Központi Kórház/Pszichiátria osztály
  • 440-PsychoTech Kft.Recruiting
  • 489-St. Gyorgy Hospital
  • 580-AOU Consorziale Policlinico di Bari
  • 552-Ospedale Versilia, UOC Psichiatria
  • 539-Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico U.O.C. Psichiatria - Padiglione Alfieri, primo piano
  • 566-Ospedale San Raffaele (San Raffaele Turro)Recruiting
  • 577-ASST di Monza (Presidio San Gerardo)
  • 553-AO Città della Salute e della Scienza di Torino
  • 516-Neuromeda, JSC
  • 483-Romuvos klinika, UAB
  • 518-Kaunas City Outpatient Clinic, Public Institution
  • Silutes Mental Health and Psychotherapy Center, JSC
  • 484-Medical Center Puriena JSC
  • 517-Zirmunai Mental Health Center, Public Institution
  • 514-Antakalnis Psychiatric Consultation Center, Public Institution
  • 525-Podlaskie Centrum PsychogeriatriiRecruiting
  • 502-Przychodnia Srodmiescie Sp. z o. o.
  • 442-Clinsante S.C. Osrodek Badan Klinicznych
  • 579-Centrum Badan Klinicznych P.I. House Sp. z o.o.Recruiting
  • 541-Care Clinic centrum Medyczne
  • 503-NZOZ Poradnia Zdrowia Psychicznego
  • 504-Centrum Medyczne "Luxmed" Sp. z o.o.
  • 501-Specjalistyczna Praktyka Lekarska Marek DomańskiRecruiting
  • 500-NZOZ Syntonia
  • 578-MSCZ im. Prof. J. Mazurkiewicza
  • 540-Ośr. Badań Klin. CLINSANTE S.C.
  • 505-GUZ Lipetsk Regional psychoneurological Hospital #1
  • 417-State Budget Healthcare Institution of Stavropol Region (Regional Specialized Psychiatric Hospital #2)Recruiting
  • 418-State Budget Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Psychiatric Hospital"
  • 506-Sverdlov Regional Psychiatric Clinical Hospital
  • 419-State municipal healthcare Institution "Leningrad region psychoneurological center"
  • 459-Federal State Budgetary Research Institution "Mental Health Science Center"
  • 573-SBIH of Moscow "Psychiatric Clinical Hospital # 4 n.a. P.B. Gannushkin" Short name: PCH N4 n.a. P.B.GannushkinRecruiting
  • 581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"Recruiting
  • 415-Saint-Petersburg State Healthcare Institution "Saint Nicolas Wonderworker Psychiatric Hospital"Recruiting
  • 451-V. M. Bekhterev National Research Medical Center For Psychiatry and NeurologyRecruiting
  • 453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"Recruiting
  • 465-"Saint-Petersburg Scientific Research Psychoneurological Institute N.A. V.M. Bekhterev"Recruiting
  • 495-FSBI "National Medical Scientifi Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoHRecruiting
  • 443-Saint-Petersburg State Budget Healthcare Institution "Psychoneurological Center #5"
  • 444-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov"Recruiting
  • 452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a.I.I. Skvortsov-StepanovRecruiting
  • 496-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-StepanovRecruiting
  • 458-State Budget Healthcare Institution "Samara Psychiatric Hospital"Recruiting
  • 490-SHI City Psychoneurological Dispensary #7 with Hospital
  • 571-St. Petersburg SHI "Psychoneurological Dispensary #10"Recruiting
  • 464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)"Recruiting
  • 416-FSBEI HE "Smolensk State Medical University" of the MoH of the RFRecruiting
  • 420-"Podderzhka" Research and Educational Center of Psychotherapy Limited Liability Company
  • 572-Klinika StoLet" Ltd.Recruiting
  • 466-OOO "Lion-Med"
  • 422-State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Psychiatric Hospital"Recruiting
  • 428-Clinical center of Serbia
  • 425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of PsychiatryRecruiting
  • 471-Clinic for Psychiatric Diseases "Dr Laza Lazarevic"
  • 522-Military Medical Academy Clinic of Psychiatry
  • 524-General Hospital Euromedik
  • 424-Institute of Mental healthRecruiting
  • 587-Institute of Mental HealthRecruiting
  • 584-Clinic for Psychiatry, Clinical Canter of Serbia
  • 472-Special Hospital for Psychiatric Diseases "Kovin"
  • 493-Special Neuropsychiatric Hospital Kovin
  • 423-Clinical Center KragujevacRecruiting
  • 429-Clinical Center Kragujevac, Clinic of Psychiatry
  • 430-Psychiatric Clinic, Clinical Center KragujevacRecruiting
  • 427-Clinical Center Nis, Clinic of Mental HealthRecruiting
  • 585-Special Hospital for Psychiatric Diseases "Gornja Toponica"Recruiting
  • 593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
  • 476-FIDMAG Germanes Hospitalaries
  • 574-Hospital Clinic de BarcelonaRecruiting
  • 576-Hospital Universitari Vall d'Hebron
  • 588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos
  • 475-Hospital Gregorio Marañon
  • 445-Hospital del Henares
  • 575-Hospital Universitario 12 de OctubreRecruiting
  • 494-CSM La CorredoriaRecruiting
  • 431-Centro de Salud Parquesol, 2ª planta - Servicio de PsiquiatriaRecruiting
  • 529-Hospital Provincial de ZamoraRecruiting
  • 438-Communal Establishment "Odesa Regional Psychiatric Hospital #2"
  • 436-Public Medicoprophylactic Institution "Chernihiv Regional Psychoneurologic Hospital", Psychiatric Department #18
  • 462-Communal Establishment "I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital"
  • 510-CI of Kyiv RC Regional Psychiatric-Narcological Medical Association, Depart #10 (male), Dept #2 (female)
  • 433-SI "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine"
  • 434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and NarcologyRecruiting
  • 582-SI Institute of Neurology,Psychiatry&Narcology of NAMSURecruiting
  • 567-CIH Kharkiv Regional Clinical Psychiatric Hospital #3 Psychiatric Department of Primary Psychotic Episod Short Site name: CIH KRCPH #3 PD of PPERecruiting
  • 461-Kherson Regional Psychiatric Hospital
  • 507-Main Military Clinical Hospital of MDU
  • 437-Kyiv City Psychoneurological Hospital #2 Kyiv City Psychoneurological Hospital #2 Consultative Department
  • 447-Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of Ministry of Healthcare of Ukraine
  • Kyiv Regional Medical Incorporation Psychiatry Center of Novel Treatment and Rehabilitation of Psychotic Disorders, Department #29, Department #30Recruiting
  • 460-Kyiv City Psychoneurological Hospital #3, General Psychiatry Department No. 2
  • 435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30Recruiting
  • 565-Kyiv CH on Railway Transport #2 of Branch Center of Healthcare Public Company Ukr Railway Short site name: Kyiv Railway Clinical Hospital № 2
  • 523-CI of LRC Lviv Regional Psychoneurology Dispensary
  • 446-CI Lviv Regional Clinical Psychiatric Hospital Dept #20
  • 564-Regional Clinical Psychiatric HospitalRecruiting
  • 509-CI Odesa Regional Medical Centre of Mental HealthRecruiting
  • 448-Poltava Regional Clinical Psychiatric Hospital n.a. O.F. Maltsev
  • 508-CI Cherkasy Regional Psychiatric Hospital of ChRC Female Dept #11, Male Dept #12Recruiting
  • Communal Establishment "Acad. O.I. Iushchenko Vinnytsia Regional Psychoneurologic Hospital"
  • 432-Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko", Male Department No 14, Female Department No 15, Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept of Psychiatry, Narcology and Psychothera
  • 591-Municipal non-profit enterprise "Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions" of the Transcarpathian Regional Council, Department of psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug - Pimavanserin

Arm Description

Pimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth

Outcomes

Primary Outcome Measures

Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability])
Evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

Secondary Outcome Measures

Full Information

First Posted
April 13, 2017
Last Updated
August 15, 2023
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03121586
Brief Title
Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Official Title
A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2017 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug - Pimavanserin
Arm Type
Experimental
Arm Description
Pimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Intervention Description
Pimavanserin 10 mg, tablet, taken as one 10 mg tablets, once daily by mouth, OR Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
Primary Outcome Measure Information:
Title
Evaluate the long-term safety and tolerability of pimavanserin (e.g., Summary of Treatment-Emergent Adverse Events [Safety and Tolerability])
Description
Evaluate the long-term safety and tolerability of pimavanserin after 52 weeks of adjunctive treatment in subjects with schizophrenia
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is able to understand and provide signed informed consent Has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) considered reliable by the Investigator in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures and who is also able to provide input helpful for completing study rating scale Is completing the Week 6 visit in Study ACP-103-034 or the Week 26 visit in Study ACP-103-038 or 064 while continuing to take his/her assigned dose of blinded study drug and may, in the Investigator's opinion, benefit from continued adjunctive treatment with pimavanserin to a antipsychotic If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use two clinically acceptable methods of contraception The main background antipsychotic with which the subject is being treated must continue to be on one of the antipsychotics listed below: Aripiprazole Aripiprazole long-acting injectables: Abilify Maintena® Aristada® Asenapine Risperidone Risperidone long-acting injection Olanzapine Paliperidone extended release (ER) (≤9 mg) Paliperidone palmitate Invega Sustenna® (≤156 mg) Invega Trinza® (≤546 mg) Trevicta® (≤350 mg) Xeplion® (≤100 mg) Lurasidone Cariprazine Brexpiprazole Asenapine Exclusion Criteria: Patient is judged by the Investigator or the Medical Monitor to be inappropriate for the study (e.g., significantly noncompliant in Studies ACP-103-034, -038, or -064) A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse Subjects from Studies 034 and 038 with a result indicating the presence of marijuana are permitted, if allowed by medical regulations, if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation Subjects from Study 064 with a result indicating the presence of marijuana are not permitted in the study Is taking a medication or drug or other substance that is prohibited according to this protocol Known family or personal history or symptoms of long QT syndrome or risk factors for torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dragana Bugarski-Kirola, MD
Phone
609-250-6903
Email
dbugarski-kirola@acadia-pharm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Filosi
Phone
609-250-6920
Email
sfilosi@acadia-pharm.com
Facility Information:
Facility Name
171-Alea Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Completed
Facility Name
156-Woodland International Research Group, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Completed
Facility Name
111-Woodland Research Northwest, LLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Completed
Facility Name
154-Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Withdrawn
Facility Name
167-CITrials - Bellflower
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Individual Site Status
Completed
Facility Name
147-Comprehensive Clinical Development
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Individual Site Status
Withdrawn
Facility Name
105-ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Completed
Facility Name
121-Behavioral Research Specialists, LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Withdrawn
Facility Name
123-Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Individual Site Status
Completed
Facility Name
150-Apostle Clinical Trials, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Individual Site Status
Withdrawn
Facility Name
126-Long Beach VA Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Individual Site Status
Withdrawn
Facility Name
120-Pacific Institute of Medical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Withdrawn
Facility Name
107-Pacific Research Partners, LLC
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Individual Site Status
Withdrawn
Facility Name
164-Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Completed
Facility Name
122-Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Withdrawn
Facility Name
165-CITrials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Completed
Facility Name
108-Collaborative Nueroscience Network, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Completed
Facility Name
112-Flagship Norwalk, LLC
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
90650
Country
United States
Individual Site Status
Withdrawn
Facility Name
158-Charles E. Schmidt College of Medicine Florida Atlantic University
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Individual Site Status
Withdrawn
Facility Name
119-Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Individual Site Status
Withdrawn
Facility Name
125-Galiz Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Completed
Facility Name
132-Clinical Neuroscience Solutions Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Withdrawn
Facility Name
137-Innovative Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Individual Site Status
Completed
Facility Name
146-Premier Clinical Research Institute, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Completed
Facility Name
149-Miller School of Medicine University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Withdrawn
Facility Name
166-Meridien Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Individual Site Status
Withdrawn
Facility Name
163-Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Withdrawn
Facility Name
162-Synexus Clinical Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Completed
Facility Name
168-Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Completed
Facility Name
135-Georgia Regents University, Department of Psychiatry & Behavioral Health
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Withdrawn
Facility Name
152-iResearch Atlanta LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Withdrawn
Facility Name
102-Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Completed
Facility Name
114-Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Completed
Facility Name
101-American Medical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Completed
Facility Name
130-Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Individual Site Status
Completed
Facility Name
133-Department of Psychiatry and Behavioral Sciences KU School of Medicine-Wichita - 133
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Withdrawn
Facility Name
118-Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Individual Site Status
Completed
Facility Name
116-Louisiana Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Individual Site Status
Withdrawn
Facility Name
157-Maryland Psychiatric Research Center
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Individual Site Status
Withdrawn
Facility Name
151-Michigan Clinical Research Institute PC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Withdrawn
Facility Name
134-Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39110
Country
United States
Individual Site Status
Withdrawn
Facility Name
113-St. Charles Psychiatric Associates Midwest Research Group
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Individual Site Status
Withdrawn
Facility Name
148-Washington University School of Medicine St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Withdrawn
Facility Name
109-St. Louis Clinical Trials, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Withdrawn
Facility Name
143-Premier Psychiatric Research Institute, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Withdrawn
Facility Name
124-Altea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Completed
Facility Name
141-Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Completed
Facility Name
169-PRA Health Sciences
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Individual Site Status
Withdrawn
Facility Name
153-Albuquerque Neuroscience Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Completed
Facility Name
104-Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Individual Site Status
Completed
Facility Name
140-Synexus Clinical Research, Inc - 140
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Individual Site Status
Completed
Facility Name
128-Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Individual Site Status
Completed
Facility Name
106-New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Completed
Facility Name
145-Carolina Behavioral Care
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Individual Site Status
Completed
Facility Name
139-University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Withdrawn
Facility Name
138-Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Withdrawn
Facility Name
129-Insight Clinical Trials, LLC
City
Shaker Heights
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Withdrawn
Facility Name
110-Cutting Edge Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Individual Site Status
Completed
Facility Name
170-Suburban Research Associates
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Individual Site Status
Completed
Facility Name
144-Carolina Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Withdrawn
Facility Name
155-Bayou City Research, Ltd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Individual Site Status
Withdrawn
Facility Name
127-University Hills Clinical Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Individual Site Status
Completed
Facility Name
103-Pillar Clinical Research, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Individual Site Status
Completed
Facility Name
115-Psychiatric and Behavioral Solutions LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States
Individual Site Status
Completed
Facility Name
610-Clinica Privada Banfield S.A.
City
Buenos Aires
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
603-Fundación para el Estudio y Tratamiento de las Enfermedades Mentales - FETEM
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Name
625-NOVAIN Neurociencias Group
City
Ciudad Autonoma de Buenos Aires
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
601-CENydET- Centro Neurobiologico y de Estres Traumatico-Biopsychomedical Research Group SRL
City
Ciudad Autonoma de Buenos Aire
Country
Argentina
Individual Site Status
Recruiting
Facility Name
602-FunDamoS
City
Ciudad Autonoma de Buenos Aire
Country
Argentina
Individual Site Status
Recruiting
Facility Name
607-Resolution Psicopharmacology Research Institute
City
Ciudad de Mendoza
Country
Argentina
Individual Site Status
Recruiting
Facility Name
626-Sanatorio Prof. Leon S. Morra S.A.
City
Cordoba
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
622-Instituto Medico Damic Srl
City
Córdoba
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
624-Centro Especializado en Neurociencias CEN
City
Córdoba
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
617-INSA Instituto de Neurociencias San Agustin S.A.
City
La Plata
Country
Argentina
Individual Site Status
Recruiting
Facility Name
623-Clinica Privada de Salud Mental Santa Teresa de Avila
City
La Plata
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
454-Mental Health Centre 'Prof. Dr. Ivan Temkov', EOOD
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
533-State Psychiatric Hospital - Kardzhali, EOOD
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
532-MHAT "Dr. Hristo Stambolski", EOOD
City
Kazanlak
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
569-State Psychiatric Hospital - Lovech
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
406-State Psychiatric Hospital - Pazardzhik AD
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Individual Site Status
Completed
Facility Name
535-UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
586-Medical Center Mentalcare OOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
563-MC-Hipokrat-N E00D
City
Plovdiv
ZIP/Postal Code
4028
Country
Bulgaria
Individual Site Status
Completed
Facility Name
403-University Multiprofile hospital for activated treatment Sveti Georgi, Clinic of psychiatry
City
Plovdiv
Country
Bulgaria
Individual Site Status
Completed
Facility Name
592-Medical center Spectar - Plovdiv EOOD
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
570-Medical Centre "Sveti Naum"
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
497-MHC - Sofia, EOOD
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Individual Site Status
Completed
Facility Name
526-DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
402-Military Medical Academy, Multiprofile Hospital for Actie Treatment - Sofia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Completed
Facility Name
405-UMHAT "Alexandrovska" EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
568-Medical Center Hera EOOD
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
528-Medical Center Intermedica, OOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
404-MHAT-Targovishte, AD
City
Targovishte
ZIP/Postal Code
7700
Country
Bulgaria
Individual Site Status
Completed
Facility Name
590-State Psychiatric Hospital - Tzarev Brod
City
Tsarev Brod
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
407-State Psychiatric Hospital - Tserova Koria
City
Tserova Koria
ZIP/Postal Code
5047
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
498-DCC "Mladost M" - Varna, OOD
City
Varna
ZIP/Postal Code
9020
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
455-Mental Health Center - Veliko Tarnovo EOOD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
401-Mental Health Center-Vratsa EOOD
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Dr. Alexander McIntyre Inc.
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 4M4
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Chatham-Kent Clinical Trials Research Ctr
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L1C1
Country
Canada
Individual Site Status
Completed
Facility Name
352 - Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Withdrawn
Facility Name
351-McGill University Health Ctr Allan Memorial Int.
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Individual Site Status
Completed
Facility Name
356-Chatham-Kent Clinical Trials Research Ctr
City
Chatham
ZIP/Postal Code
N7L 1C1
Country
Canada
Individual Site Status
Completed
Facility Name
354-Queens University at Kingston, Providence Care Hospital
City
Kingston
ZIP/Postal Code
K7L 4X3
Country
Canada
Individual Site Status
Withdrawn
Facility Name
355-Sunny Johnson Medical Research Associates
City
Mississauga
ZIP/Postal Code
L5M 4N4
Country
Canada
Individual Site Status
Withdrawn
Facility Name
357-Dr. Alexander McIntyre Inc.
City
Penticton
ZIP/Postal Code
V2A 4M4
Country
Canada
Individual Site Status
Withdrawn
Facility Name
536 - Clinic for psychiatry Vrapce
City
Zagreb
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
537 - Clinic for psychiatry Vrapce
City
Zagreb
Country
Croatia
Individual Site Status
Recruiting
Facility Name
550-Clinic for psychiatry Vrapce
City
Zagreb
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
557 - Clinic for psychiatry Vrapce
City
Zagreb
Country
Croatia
Individual Site Status
Recruiting
Facility Name
594-Klinika za psihijatriju Sveti Ivan, n/p Igor Filipčić or Marija Zelenika
City
Zagreb
Country
Croatia
Individual Site Status
Not yet recruiting
Facility Name
512-NeuropsychiatrieHK s.r.o.
City
Hradec Králové
ZIP/Postal Code
50341
Country
Czechia
Individual Site Status
Recruiting
Facility Name
583-Narodni ustav dusevniho zdravi
City
Klecany
Country
Czechia
Individual Site Status
Recruiting
Facility Name
519-A-SHINE s.r.o.
City
Plzen
ZIP/Postal Code
31200
Country
Czechia
Individual Site Status
Recruiting
Facility Name
513-CLINTRIAL s.r.o.
City
Praha 10
ZIP/Postal Code
10000
Country
Czechia
Individual Site Status
Completed
Facility Name
499-MUDr. Tibor Miklos
City
Praha 10
ZIP/Postal Code
10600
Country
Czechia
Individual Site Status
Completed
Facility Name
491-MEDICAL SERVICES PRAGUE s.r.o.
City
Praha 6
ZIP/Postal Code
16000
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
511-Psychiatrie Ricany s.r.o.
City
Říčany
ZIP/Postal Code
25101
Country
Czechia
Individual Site Status
Completed
Facility Name
410-Dr. Máthé és Társa Bt.
City
Kalocsa
State/Province
Bács-Kiskun Megye
ZIP/Postal Code
6300
Country
Hungary
Individual Site Status
Recruiting
Facility Name
411-ÓBudai Egészségűgyi Centrum Kft
City
Budapest
State/Province
Pest Megye
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Completed
Facility Name
456-Semmelweis University Department of Psychiatry and Psychotherapy
City
Budapest
State/Province
Pest Megye
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
521-Jozsefvarosi Szent Kozma Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1084
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
520-Nyiro Gyula Korhaz - Orszagos Pszichiatriai es Addiktologiai Intezet
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Individual Site Status
Completed
Facility Name
527-Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
412-Békés Megyei Központi Kórház/Pszichiátria osztály
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
440-PsychoTech Kft.
City
Pécs
ZIP/Postal Code
7633
Country
Hungary
Individual Site Status
Recruiting
Facility Name
489-St. Gyorgy Hospital
City
Székesfehérvár
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
580-AOU Consorziale Policlinico di Bari
City
Bari
Country
Italy
Individual Site Status
Withdrawn
Facility Name
552-Ospedale Versilia, UOC Psichiatria
City
Lido di Camaiore
Country
Italy
Individual Site Status
Withdrawn
Facility Name
539-Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico U.O.C. Psichiatria - Padiglione Alfieri, primo piano
City
Milano
Country
Italy
Individual Site Status
Withdrawn
Facility Name
566-Ospedale San Raffaele (San Raffaele Turro)
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Name
577-ASST di Monza (Presidio San Gerardo)
City
Monza
Country
Italy
Individual Site Status
Withdrawn
Facility Name
553-AO Città della Salute e della Scienza di Torino
City
Torino
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
516-Neuromeda, JSC
City
Kaunas
ZIP/Postal Code
50185
Country
Lithuania
Individual Site Status
Withdrawn
Facility Name
483-Romuvos klinika, UAB
City
Kaunas
ZIP/Postal Code
LT-44279
Country
Lithuania
Individual Site Status
Completed
Facility Name
518-Kaunas City Outpatient Clinic, Public Institution
City
Kaunas
ZIP/Postal Code
LT-48259
Country
Lithuania
Individual Site Status
Completed
Facility Name
Silutes Mental Health and Psychotherapy Center, JSC
City
Silute
ZIP/Postal Code
99142
Country
Lithuania
Individual Site Status
Withdrawn
Facility Name
484-Medical Center Puriena JSC
City
Silute
Country
Lithuania
Individual Site Status
Completed
Facility Name
517-Zirmunai Mental Health Center, Public Institution
City
Vilnius
ZIP/Postal Code
09112
Country
Lithuania
Individual Site Status
Completed
Facility Name
514-Antakalnis Psychiatric Consultation Center, Public Institution
City
Vilnius
ZIP/Postal Code
10204
Country
Lithuania
Individual Site Status
Withdrawn
Facility Name
525-Podlaskie Centrum Psychogeriatrii
City
Białystok
ZIP/Postal Code
15-756
Country
Poland
Individual Site Status
Recruiting
Facility Name
502-Przychodnia Srodmiescie Sp. z o. o.
City
Bydgoszcz
ZIP/Postal Code
85-080
Country
Poland
Individual Site Status
Completed
Facility Name
442-Clinsante S.C. Osrodek Badan Klinicznych
City
Bydgoszcz
Country
Poland
Individual Site Status
Withdrawn
Facility Name
579-Centrum Badan Klinicznych P.I. House Sp. z o.o.
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Recruiting
Facility Name
541-Care Clinic centrum Medyczne
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Individual Site Status
Withdrawn
Facility Name
503-NZOZ Poradnia Zdrowia Psychicznego
City
Kobierzyce
Country
Poland
Individual Site Status
Withdrawn
Facility Name
504-Centrum Medyczne "Luxmed" Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
Individual Site Status
Withdrawn
Facility Name
501-Specjalistyczna Praktyka Lekarska Marek Domański
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Name
500-NZOZ Syntonia
City
Pruszcz Gdański
ZIP/Postal Code
83-000
Country
Poland
Individual Site Status
Withdrawn
Facility Name
578-MSCZ im. Prof. J. Mazurkiewicza
City
Pruszków
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
540-Ośr. Badań Klin. CLINSANTE S.C.
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Withdrawn
Facility Name
505-GUZ Lipetsk Regional psychoneurological Hospital #1
City
Plekhanovo
State/Province
Lipetsk Region
ZIP/Postal Code
399313
Country
Russian Federation
Individual Site Status
Completed
Facility Name
417-State Budget Healthcare Institution of Stavropol Region (Regional Specialized Psychiatric Hospital #2)
City
Tonnel'nyy
State/Province
Stavropol Region
ZIP/Postal Code
357034
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
418-State Budget Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Psychiatric Hospital"
City
Arkhangel'sk
ZIP/Postal Code
163530
Country
Russian Federation
Individual Site Status
Completed
Facility Name
506-Sverdlov Regional Psychiatric Clinical Hospital
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
419-State municipal healthcare Institution "Leningrad region psychoneurological center"
City
Leningrad
ZIP/Postal Code
188820
Country
Russian Federation
Individual Site Status
Completed
Facility Name
459-Federal State Budgetary Research Institution "Mental Health Science Center"
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Completed
Facility Name
573-SBIH of Moscow "Psychiatric Clinical Hospital # 4 n.a. P.B. Gannushkin" Short name: PCH N4 n.a. P.B.Gannushkin
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
581-SBIH of Moscow "Psych Clinical Hospital #1 N.A. Alekseev"
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
415-Saint-Petersburg State Healthcare Institution "Saint Nicolas Wonderworker Psychiatric Hospital"
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
451-V. M. Bekhterev National Research Medical Center For Psychiatry and Neurology
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
453-"Saint-Petersburg Scientific Research Psychoneurological Institute n.a. V.M. Bekhterev"
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
465-"Saint-Petersburg Scientific Research Psychoneurological Institute N.A. V.M. Bekhterev"
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
495-FSBI "National Medical Scientifi Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
443-Saint-Petersburg State Budget Healthcare Institution "Psychoneurological Center #5"
City
Saint Petersburg
ZIP/Postal Code
195112
Country
Russian Federation
Individual Site Status
Completed
Facility Name
444-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov"
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
452-Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 n.a.I.I. Skvortsov-Stepanov
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
496-SPHI "City Mental Hospital #3 n.a. I.I Skvortsov-Stepanov
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
458-State Budget Healthcare Institution "Samara Psychiatric Hospital"
City
Saint Petersburg
ZIP/Postal Code
443016
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
490-SHI City Psychoneurological Dispensary #7 with Hospital
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
571-St. Petersburg SHI "Psychoneurological Dispensary #10"
City
Saint-Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
464-Saint Petersburg State Budget Healthcare Institution "City Psychiatric Hospital No. 6 (Inpatient Department with Treatment Center)"
City
Saint-Petersburg
ZIP/Postal Code
193167
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
416-FSBEI HE "Smolensk State Medical University" of the MoH of the RF
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
420-"Podderzhka" Research and Educational Center of Psychotherapy Limited Liability Company
City
Stavropol'
ZIP/Postal Code
355000
Country
Russian Federation
Individual Site Status
Completed
Facility Name
572-Klinika StoLet" Ltd.
City
Tomsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
466-OOO "Lion-Med"
City
Voronezh
ZIP/Postal Code
394024
Country
Russian Federation
Individual Site Status
Completed
Facility Name
422-State Budget Healthcare Institution of Yaroslavl Region "Yaroslavl Region Clinical Psychiatric Hospital"
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
428-Clinical center of Serbia
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Individual Site Status
Completed
Facility Name
425-Clinical Hospital Center "Dr. Dragisa Misovic-Dedinje", Clinic of Psychiatry
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
471-Clinic for Psychiatric Diseases "Dr Laza Lazarevic"
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Completed
Facility Name
522-Military Medical Academy Clinic of Psychiatry
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Withdrawn
Facility Name
524-General Hospital Euromedik
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Completed
Facility Name
424-Institute of Mental health
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
587-Institute of Mental Health
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
584-Clinic for Psychiatry, Clinical Canter of Serbia
City
Belgrad
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
472-Special Hospital for Psychiatric Diseases "Kovin"
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Completed
Facility Name
493-Special Neuropsychiatric Hospital Kovin
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Completed
Facility Name
423-Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
429-Clinical Center Kragujevac, Clinic of Psychiatry
City
Kragujevac
ZIP/Postal Code
34 000
Country
Serbia
Individual Site Status
Completed
Facility Name
430-Psychiatric Clinic, Clinical Center Kragujevac
City
Kragujevac
Country
Serbia
Individual Site Status
Recruiting
Facility Name
427-Clinical Center Nis, Clinic of Mental Health
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
585-Special Hospital for Psychiatric Diseases "Gornja Toponica"
City
Niš
Country
Serbia
Individual Site Status
Recruiting
Facility Name
593-Specialized Hospital for Neuropsychiatric Diseases "Sveti Vracevi"
City
Novi Kneževac
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
476-FIDMAG Germanes Hospitalaries
City
Barcelona
ZIP/Postal Code
08830
Country
Spain
Individual Site Status
Completed
Facility Name
574-Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
576-Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Withdrawn
Facility Name
588-Institucion Hospitalaria Hestia Palau - Ensayos clinicos
City
Barcelona
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
475-Hospital Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Completed
Facility Name
445-Hospital del Henares
City
Madrid
Country
Spain
Individual Site Status
Withdrawn
Facility Name
575-Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
494-CSM La Corredoria
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
431-Centro de Salud Parquesol, 2ª planta - Servicio de Psiquiatria
City
Valladolid
ZIP/Postal Code
47016
Country
Spain
Individual Site Status
Recruiting
Facility Name
529-Hospital Provincial de Zamora
City
Zamora
ZIP/Postal Code
49021
Country
Spain
Individual Site Status
Recruiting
Facility Name
438-Communal Establishment "Odesa Regional Psychiatric Hospital #2"
City
Odessa
State/Province
Oblast
ZIP/Postal Code
67513
Country
Ukraine
Individual Site Status
Completed
Facility Name
436-Public Medicoprophylactic Institution "Chernihiv Regional Psychoneurologic Hospital", Psychiatric Department #18
City
Chernihiv
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
462-Communal Establishment "I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital"
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Completed
Facility Name
510-CI of Kyiv RC Regional Psychiatric-Narcological Medical Association, Depart #10 (male), Dept #2 (female)
City
Hlevakha
ZIP/Postal Code
08631
Country
Ukraine
Individual Site Status
Completed
Facility Name
433-SI "Institute of Neurology, Psychiatry and Narcology of National Academy of Medical Sciences of Ukraine"
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Completed
Facility Name
434-State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine", Department of Urgent Psychiatry and Narcology
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
582-SI Institute of Neurology,Psychiatry&Narcology of NAMSU
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
567-CIH Kharkiv Regional Clinical Psychiatric Hospital #3 Psychiatric Department of Primary Psychotic Episod Short Site name: CIH KRCPH #3 PD of PPE
City
Kharkiv
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
461-Kherson Regional Psychiatric Hospital
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Individual Site Status
Completed
Facility Name
507-Main Military Clinical Hospital of MDU
City
Kyiv
ZIP/Postal Code
01133
Country
Ukraine
Individual Site Status
Completed
Facility Name
437-Kyiv City Psychoneurological Hospital #2 Kyiv City Psychoneurological Hospital #2 Consultative Department
City
Kyiv
ZIP/Postal Code
02192
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
447-Ukrainian Scientific Research Institute of Social and Forensic Psychiatry and Narcology of Ministry of Healthcare of Ukraine
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Individual Site Status
Completed
Facility Name
Kyiv Regional Medical Incorporation Psychiatry Center of Novel Treatment and Rehabilitation of Psychotic Disorders, Department #29, Department #30
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
460-Kyiv City Psychoneurological Hospital #3, General Psychiatry Department No. 2
City
Kyiv
ZIP/Postal Code
08631
Country
Ukraine
Individual Site Status
Completed
Facility Name
435-Kyiv Regional Medical Incorporation "Psychiatry". Center of Novel Treatment and Rehabilitation of Psychotic disorders, build 5, Department #30
City
Kyiv
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
565-Kyiv CH on Railway Transport #2 of Branch Center of Healthcare Public Company Ukr Railway Short site name: Kyiv Railway Clinical Hospital № 2
City
Kyiv
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
523-CI of LRC Lviv Regional Psychoneurology Dispensary
City
Lviv
ZIP/Postal Code
79017
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
446-CI Lviv Regional Clinical Psychiatric Hospital Dept #20
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
564-Regional Clinical Psychiatric Hospital
City
Nove
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
509-CI Odesa Regional Medical Centre of Mental Health
City
Odesa
ZIP/Postal Code
65014
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
448-Poltava Regional Clinical Psychiatric Hospital n.a. O.F. Maltsev
City
Poltava
ZIP/Postal Code
36013
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
508-CI Cherkasy Regional Psychiatric Hospital of ChRC Female Dept #11, Male Dept #12
City
Smila
ZIP/Postal Code
20708
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Communal Establishment "Acad. O.I. Iushchenko Vinnytsia Regional Psychoneurologic Hospital"
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Individual Site Status
Completed
Facility Name
432-Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I. Yushchenko", Male Department No 14, Female Department No 15, Vinnytsya National Medical University n.a. M.I. Pyrogov, Dept of Psychiatry, Narcology and Psychothera
City
Vinnytsia
Country
Ukraine
Individual Site Status
Completed
Facility Name
591-Municipal non-profit enterprise "Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions" of the Transcarpathian Regional Council, Department of psychiatry
City
Úzhgorod
Country
Ukraine
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia

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