Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Schizophrenia
About this trial
This is an interventional treatment trial for Schizophrenia
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).
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
Experimental
Drug - Pimavanserin
Pimavanserin 34 mg, 20 mg, or 10 mg, + background antipsychotic, taken once daily by mouth