Back to resultsA Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SEP-363856
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Subject (or subject's parent/legal guardian for adolescents) must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.
- Subject has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
- Subject has not taken any medication other than the study drug and protocol-allowed medications for the purpose of controlling schizophrenia symptoms during Study SEP361-301 or SEP361-302.
- Female subject must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.
- Female subjects of childbearing potential must agree to use highly effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken.
- Male subjects must agree to avoid fathering a child and use highly effective methods of birth control from screening in Study SEP361-301 or Study SEP361-302, until at least 30 days after the last study drug administration in the present study (SEP361-303).
Exclusion Criteria
- . Subject answered "yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) assessment at the End of treatment (EO) Visit of Study SEP361-301 or SEP361-302.
- Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at the EOT Visit of Study SEP361-301 or SEP361-302 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
- Subject has a positive urine drug screen (UDS) at the EOT Visit of Study SEP361-301 or SEP361-302. However, a positive UDS test may not result in exclusion of subjects if the Investigator determines that the positive test is as a result of prescription medicine(s). Subjects may enter this study before the urine drug screen results are received from the central laboratory. However, after receipt and review of the results any subject meeting this exclusion criterion must be discontinued from the study. Retesting of the UDS is allowed once with prior approval from the Medical Monitor with the retest used to determine eligibility
- Female subject is pregnant or lactating.
Sites / Locations
- Woodland International Research Group, LLC
- Woodland Research Northwest
- Advanced Research Center, Inc.Recruiting
- ProScience Research GroupRecruiting
- Synergy San DiegoRecruiting
- Collaborative Neuroscience NetworkRecruiting
- Alliance for ResearchRecruiting
- Catalina Research InstituteRecruiting
- California Neuropsychopharmacology Clinical research Institute (CNRI-LA, LLC)Recruiting
- California Neuropsychopharmacology clinical Research InstituteRecruiting
- Schuster Medical Research InstituteRecruiting
- South Florida Research Phase I-IV, Inc.Recruiting
- Fort Lauderdale Behavioral Health Center
- iResearch Atlanta, LLCRecruiting
- Advanced Discovery Research LLCRecruiting
- Atlanta Center for Medical Research
- iResearch Atlanta, LLCRecruiting
- Lake Charles Clinical TrialsRecruiting
- CBH Health, LLCRecruiting
- Precise Research CentersRecruiting
- Arch Clinical Trials, LLCRecruiting
- Hassman Research InstituteRecruiting
- New York State Psychiatric Institute
- Midwest Clinical research CenterRecruiting
- Dr. David Brown, Community Clinical ResearchRecruiting
- Pillar Clinical Research
- Mental Health Centre Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric ConditionsRecruiting
- State Psychiatric Hospital - Kardzhali, First Women Department, Third Men DepartmentRecruiting
- State Psychiatric Hospital Sv. Ivan Rilski, Department general Psychiatry for Adults, "Closed" type - Men, Department General Psychiatry for Adults, "Closed" Type WomenRecruiting
- State Psychiatric Hospital-Pazardzhik AD, Department for Active Treatment of Men Department for Active Treatment of Women , Department of Active Treatment of Men and WomenRecruiting
- UMHAT-Dr. Georgi Stranski EAD, First Psychiatric ClinicRecruiting
- UMHAT Alexandrovska EAD First Department of Psychiatry at Clinic of PsychiatryRecruiting
- UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of PsychiatryRecruiting
- Mental Health Center - Veliko Tarnovo EOOD-Department of psychiatry for active treatment of persons with acute psychiotic disordersRecruiting
- Mental Health Center-Vratsa EOOD, Department of General PsychiatryRecruiting
- Centro de Investigaciones y Proyectos en Neurociencias CIPNARecruiting
- Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE LtdaRecruiting
- Psychiatric Hospital "Sveti Ivan"Recruiting
- LTD Psychoneurological Hospital of Daugavpils
- SLLC Riga Centre of Psychiatry and Narcology
- SLLC Psychoneurological Hospital of StrenciRecruiting
- State Budgetary Institution of Healthcare "Regional Clinical Specialized Psychiatric Hospital #1"
- State PUblic Institution of Healthcare Leningrad Regional Psychoneurological DispensaryRecruiting
- SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"
- Institution of Healthcare Moscow "Psychiatric Clinical Hospital #1 Named after N.A. Alekseev of Department of Health Moscow"
- State Budgetary institution of Healthcare of Moscow "Psychiatric Hospital №5
- State Budgetary Institution of Healthcare of Nizhniy Novgorod region " Clinical Psychiatric Hospital # 1 of Nizhniy Novgorod
- State Budgetary Institution of Healthcare of Karelia Republic "Republican Psychiatric Hospital" Mastrosy
- Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital n.a P.P. Kashchenko:
- Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hosptial named after P.P. Kashchenko, inpatient no 2 legg add: 10
- FSBI "NMRC of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF 3, Bekhtereva str, Saint Petersbur, 192019, Russia based on SPb SI of Healthcare "City Psychiatric Hospital #6"
- Federal State Budgetary Institution "National Medical Research Center o Psychiatry and Neurology named after V.M. Bekhterev" of the Ministry of Healthcare of the Russian Fereration
- Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n. a. V. M. Bekhterev" of the Ministry of Healthcare of the Russian FederationRecruiting
- Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortson"Recruiting
- State Budgetary Institution of Healthcrae "Samara Regional Clinical Psychiatric Hospital"
- State Institution of Healthcare "Saratov City Clinical Hospital # 2 named after V.I. Razumovskiy" 20 and 21 departmentRecruiting
- State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy", psychiatric departments
- State Institution of Healthcare "Regional Clinical Psychiatric Hospital of Saint Sofia"
- State Institution of Healthcare "Engels Psychiatric Hospital" Ministry of Healthcare of Saratov region
- Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology named after V. M. Bekhterev" of the Ministry of the Healthcare of Russian federation
- State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2",Recruiting
- State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"Recruiting
- Clinic of Psychiatry, Clinical Center of SerbiaRecruiting
- Clinic of Psychiatry, Clinical Center of SerbiaRecruiting
- Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of PsychiatryRecruiting
- Institute of Mental HealthRecruiting
- Institute of Mental HealthRecruiting
- Special Hospital for Psychiatric Diseases Gornja ToponicaRecruiting
- Special Neuropsychiatric Hospital Kovin
- Special Neuropsychiatric Hospital KovinRecruiting
- Clinic of Psychiatry, Clinical Center KragujevacRecruiting
- Clinic of Psychiatry, Clinical Center KragujevacRecruiting
- Clinical Center Kragujevac, Clinic of Psychiatry
- University Clinical Center Nis, Clinic of PsychiatryRecruiting
- Special Hospital for Psychiatric Diseases Sveti Vracevi, Kralja Petra IRecruiting
- Clinical Center of Vojvodina, Clinic of Psychiatry
- Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"Recruiting
- Regional Psychoneurological Hospital#3, Department of Critical Conditions and Primary Psychotic Episode for Adult Population #1, Ivano-Frankivsk National Medical University, Chair of Psychiatry, Narcology and Medical PschologyRecruiting
- Commercial Non-Commercial Enterprise of Kharkiv Regional Council Psychiatric Department of Primary Psychotic Episode
- State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary PsychiatryRecruiting
- Communal Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10,Recruiting
- Kyiv Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian Railway", Department of Psychoneurology
- National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients
- Kyiv City Psychoneurological Hospital #2Recruiting
- Territorial Medical Association Psychiatry in Kyiv, Center of Novel Methods of Treatment and Rehabilitation of Psychotic Conditions, Department #29 (male), Department #30 (female), Outpatient and Polyclinic Office at Department #30Recruiting
- Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2
- Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional clinical Psychiatric Hospital, Department #20Recruiting
- Communial Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25Recruiting
- 2-A Metalurgiv streetRecruiting
- Communal Non-commercial Enterprise Odesa Regional Medical Center of Mental Health of Odesa Regional Council, Department #6 (male), Department #12 (female)Recruiting
- Communal Institution Odesa Regional Psychiatric Hospital #2, Department #14 (female), Department #16 (male)Recruiting
- Communal Institution O.I. Yushchenko Vinnytsia Regional Psychoneurological Hospital, Female Department #10, Male Department #7, Vinnytsia M.I.Pyrogov National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate EducationRecruiting
- Communal Institution O.I.Yushchenko Vinnytsia Regional Psychoneurological Hospital, Male Department #21, Female Department #15, M.I. Pyrogov Vinnytsia National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Educatio
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SEP-363856
Arm Description
SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily
Outcomes
Primary Outcome Measures
The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation
Secondary Outcome Measures
Full Information
NCT ID
NCT04109950
First Posted
September 27, 2019
Last Updated
May 31, 2023
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04109950
Brief Title
A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
Official Title
An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
September 10, 2024 (Anticipated)
Study Completion Date
September 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, 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
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied. This study is accepting male and female participants between 13 and 65 years old who have been diagnosed with schizophrenia and have completed Study SEP361-301 or SEP361-302. This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.
Detailed Description
An open-label extension study to assess the safety and tolerability of SEP-363856 in subjects with schizophrenia This is an open-label extension study to evaluate long-term safety and tolerability of SEP-363856. This is a 52-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (25 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed the Treatment Period of one of the two following double-blind studies: Study SEP361-301 or Study SEP361-302.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
This is a 52-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (25 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed the Treatment Period of one of the two following double-blind studies: Study SEP361-301 or Study SEP361-302.
The study will consist of two periods: An Open-Label Extension (OLE) Treatment Period (up to 52 weeks); and a Follow-up visit at 7 ±2 days after last study drug dose for subjects who complete the Treatment Period and those who prematurely discontinue from the study.
The adolescent cohort includes subjects who were 13 to 17 years of age, at the time of consent in the SEP361-301 study. For adolescent subjects, a reliable informant (e.g., parent, legal guardian, or caregiver) of the subject should accompany the subject at each visit and support and monitor the subject's compliance with taking study medication.
Masking
None (Open Label)
Masking Description
open - label
Allocation
N/A
Enrollment
555 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SEP-363856
Arm Type
Experimental
Arm Description
SEP-363856 25mg, 50mg, 75mg, 100mg flexibly dosed once daily
Intervention Type
Drug
Intervention Name(s)
SEP-363856
Intervention Description
SEP-363856 25mg, 50mg, 75mg, 100mg tablet flexibly dosed once daily
Primary Outcome Measure Information:
Title
The incidence of overall Adverse Events (AEs), Serious Adverse Events (AEs), and Adverse Events (AEs) leading to discontinuation
Time Frame
53 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject (or subject's parent/legal guardian for adolescents) must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.
Subject has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
Subject has not taken any medication other than the study drug and protocol-allowed medications for the purpose of controlling schizophrenia symptoms during Study SEP361-301 or SEP361-302.
Female subject must have a negative urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-301 or Study SEP361-302.
Female subjects of childbearing potential must agree to use highly effective and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken.
Male subjects must agree to avoid fathering a child and use highly effective methods of birth control from screening in Study SEP361-301 or Study SEP361-302, until at least 30 days after the last study drug administration in the present study (SEP361-303).
Exclusion Criteria
. Subject answered "yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) assessment at the End of treatment (EO) Visit of Study SEP361-301 or SEP361-302.
Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at the EOT Visit of Study SEP361-301 or SEP361-302 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
Subject has a positive urine drug screen (UDS) at the EOT Visit of Study SEP361-301 or SEP361-302. However, a positive UDS test may not result in exclusion of subjects if the Investigator determines that the positive test is as a result of prescription medicine(s). Subjects may enter this study before the urine drug screen results are received from the central laboratory. However, after receipt and review of the results any subject meeting this exclusion criterion must be discontinued from the study. Retesting of the UDS is allowed once with prior approval from the Medical Monitor with the retest used to determine eligibility
Female subject is pregnant or lactating.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CNS Medical Director
Phone
1-866-503-6351
Email
ClinicalTrialDisclosure@sunovion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CNS Medical Director
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Woodland International Research Group, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Woodland Research Northwest
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Macina, MD
Phone
714-999-6688
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Bussel
Phone
424-227-8127
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Bari, MD
Phone
619-303-6130
Facility Name
Collaborative Neuroscience Network
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Walling, MD
Phone
714-799-7799
Facility Name
Alliance for Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Zarate-Rowell, MD
Phone
562-548-8500
Facility Name
Catalina Research Institute
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Volk, MD
Phone
909-590-8409
Facility Name
California Neuropsychopharmacology Clinical research Institute (CNRI-LA, LLC)
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Manning, MD
Phone
562-928-8601
Facility Name
California Neuropsychopharmacology clinical Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Benbow, MD
Phone
619-481-5252
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Itzchovich-Schuster, MD
Phone
818-788-0746
Facility Name
South Florida Research Phase I-IV, Inc.
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Silva-Duluc
Phone
305-418-0847
Facility Name
Fort Lauderdale Behavioral Health Center
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
iResearch Atlanta, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saundra Maass-Robinson, MD
Phone
404-537-1281
Facility Name
Advanced Discovery Research LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Purselle
Phone
470-777-8839
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saundra Maass-Robinson, MD
Phone
404-537-1281
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kashinath Yadalam, MD
Phone
337-564-6405
Facility Name
CBH Health, LLC
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Litman, MD
Phone
301-251-4702
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Kwentus
Phone
601-420-5810
Facility Name
Arch Clinical Trials, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junaid Syed
Phone
601-420-5810
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Howard Hassman, MD
Phone
856-452-9901
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Midwest Clinical research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Otto Dueno, MD
Phone
937-281-0151
Facility Name
Dr. David Brown, Community Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Brown, MD
Phone
512-323-2622
Facility Name
Pillar Clinical Research
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mental Health Centre Prof. Dr. Ivan Temkov - Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veselin Palazov, MD
Phone
+359888451225
Facility Name
State Psychiatric Hospital - Kardzhali, First Women Department, Third Men Department
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rozaliya Rangelova, MD
Phone
+35989903682
Facility Name
State Psychiatric Hospital Sv. Ivan Rilski, Department general Psychiatry for Adults, "Closed" type - Men, Department General Psychiatry for Adults, "Closed" Type Women
City
Novi Iskar
ZIP/Postal Code
1282
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsveteslava Galabova, MD
Phone
+359888589162
Facility Name
State Psychiatric Hospital-Pazardzhik AD, Department for Active Treatment of Men Department for Active Treatment of Women , Department of Active Treatment of Men and Women
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dora Atanasova, MD
Phone
+35934448812
Facility Name
UMHAT-Dr. Georgi Stranski EAD, First Psychiatric Clinic
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Stoimenova-Popova, MD
Phone
+359888227165
Facility Name
UMHAT Alexandrovska EAD First Department of Psychiatry at Clinic of Psychiatry
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgi Onchev, MD
Phone
+359898474519
Facility Name
UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vihra Milanova, MD
Phone
+359888941451
Facility Name
Mental Health Center - Veliko Tarnovo EOOD-Department of psychiatry for active treatment of persons with acute psychiotic disorders
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ognyan Nikitov, MD
Phone
+35962622625
Facility Name
Mental Health Center-Vratsa EOOD, Department of General Psychiatry
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadya Ivanova, MD
Phone
+359887422440
Facility Name
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid I Arrieta, MD
Phone
+57 605-3738832
Ext
111
Facility Name
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
City
Bogotá
ZIP/Postal Code
111166
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Cordoba, MD
Phone
+57 601-39071
Facility Name
Psychiatric Hospital "Sveti Ivan"
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor Filipčić
Phone
+385 1 3430 021
Facility Name
LTD Psychoneurological Hospital of Daugavpils
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Individual Site Status
Active, not recruiting
Facility Name
SLLC Riga Centre of Psychiatry and Narcology
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Individual Site Status
Active, not recruiting
Facility Name
SLLC Psychoneurological Hospital of Strenci
City
Strenci
ZIP/Postal Code
LV-4730
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inga Bauska, MD
Phone
+37129521701
Facility Name
State Budgetary Institution of Healthcare "Regional Clinical Specialized Psychiatric Hospital #1"
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State PUblic Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
City
Leningrad
ZIP/Postal Code
188820
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Penchul, MD
Phone
+78137864178
Facility Name
SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Institution of Healthcare Moscow "Psychiatric Clinical Hospital #1 Named after N.A. Alekseev of Department of Health Moscow"
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State Budgetary institution of Healthcare of Moscow "Psychiatric Hospital №5
City
Moscow
ZIP/Postal Code
141371
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State Budgetary Institution of Healthcare of Nizhniy Novgorod region " Clinical Psychiatric Hospital # 1 of Nizhniy Novgorod
City
Nizhniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State Budgetary Institution of Healthcare of Karelia Republic "Republican Psychiatric Hospital" Mastrosy
City
Republic Karelia
ZIP/Postal Code
186131
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital n.a P.P. Kashchenko:
City
Saint Petersburg
ZIP/Postal Code
188357
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hosptial named after P.P. Kashchenko, inpatient no 2 legg add: 10
City
Saint Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
FSBI "NMRC of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF 3, Bekhtereva str, Saint Petersbur, 192019, Russia based on SPb SI of Healthcare "City Psychiatric Hospital #6"
City
Saint Petersburg
ZIP/Postal Code
191167
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Federal State Budgetary Institution "National Medical Research Center o Psychiatry and Neurology named after V.M. Bekhterev" of the Ministry of Healthcare of the Russian Fereration
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n. a. V. M. Bekhterev" of the Ministry of Healthcare of the Russian Federation
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikhail Ivanov, MD
Phone
+7 921 930 61 67
Facility Name
Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortson"
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Sofronov, MD
Phone
+78123018654
Facility Name
State Budgetary Institution of Healthcrae "Samara Regional Clinical Psychiatric Hospital"
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State Institution of Healthcare "Saratov City Clinical Hospital # 2 named after V.I. Razumovskiy" 20 and 21 department
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Barylnik, MD
Phone
+7 927 226 68 50
Facility Name
State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy", psychiatric departments
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State Institution of Healthcare "Regional Clinical Psychiatric Hospital of Saint Sofia"
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State Institution of Healthcare "Engels Psychiatric Hospital" Ministry of Healthcare of Saratov region
City
Saratov
ZIP/Postal Code
413124
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology named after V. M. Bekhterev" of the Ministry of the Healthcare of Russian federation
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2",
City
Stavropol
ZIP/Postal Code
357034
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey V. Zolotarev, MD
Phone
+7 962 449 94 53
Facility Name
State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"
City
Talagi
ZIP/Postal Code
163530
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anatoliy B Bogdanov
Phone
+7 921 246 43 32
Facility Name
Clinic of Psychiatry, Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maja Ivkovic, PhD
Phone
+38163252201
Facility Name
Clinic of Psychiatry, Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milan Latas, Prof.
Phone
+381641303993
Facility Name
Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Diligenski, Professor
Phone
+381113679200
Facility Name
Institute of Mental Health
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cedo Miljevic, MD
Phone
+381628759575
Facility Name
Institute of Mental Health
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milica Pejovic Milovancevic, Prof.
Phone
+38163343969
Facility Name
Special Hospital for Psychiatric Diseases Gornja Toponica
City
Gornja Toponica
ZIP/Postal Code
18202
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milan Stanojkovic, MD
Phone
+381648596221
Facility Name
Special Neuropsychiatric Hospital Kovin
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Special Neuropsychiatric Hospital Kovin
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jovanka Petrovic, MD
Phone
+3816553529054
Facility Name
Clinic of Psychiatry, Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Goran Mihajlovic, PhD
Ext
+38134300320
Facility Name
Clinic of Psychiatry, Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mirjana Jovanovic, Professor
Phone
+38134370151
Facility Name
Clinical Center Kragujevac, Clinic of Psychiatry
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
University Clinical Center Nis, Clinic of Psychiatry
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violeta Slavkovic, MD
Phone
+381641321574
Facility Name
Special Hospital for Psychiatric Diseases Sveti Vracevi, Kralja Petra I
City
Novi Knezevac
ZIP/Postal Code
23330
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jovan Milovanovic, MD
Phone
+38163239962
Facility Name
Clinical Center of Vojvodina, Clinic of Psychiatry
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
City
Vrsac
ZIP/Postal Code
26300
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatjana Voskresenski, MD
Phone
+38163644404
Facility Name
Regional Psychoneurological Hospital#3, Department of Critical Conditions and Primary Psychotic Episode for Adult Population #1, Ivano-Frankivsk National Medical University, Chair of Psychiatry, Narcology and Medical Pschology
City
Ivano-Frankivsk
ZIP/Postal Code
76011
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mykhailo Vynnyk, MD
Phone
+380976287390
Facility Name
Commercial Non-Commercial Enterprise of Kharkiv Regional Council Psychiatric Department of Primary Psychotic Episode
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataliya Maruta
Phone
+380677577772
Facility Name
Communal Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10,
City
Kherson
ZIP/Postal Code
73488
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavlo Palamarchuk, MD
Phone
+38504940457
Facility Name
Kyiv Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian Railway", Department of Psychoneurology
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients
City
Kyiv
ZIP/Postal Code
01133
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Kyiv City Psychoneurological Hospital #2
City
Kyiv
ZIP/Postal Code
02192
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladyslav Demchenko, MD
Phone
+38067 408 1203
Facility Name
Territorial Medical Association Psychiatry in Kyiv, Center of Novel Methods of Treatment and Rehabilitation of Psychotic Conditions, Department #29 (male), Department #30 (female), Outpatient and Polyclinic Office at Department #30
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuliya Blazhevych, MD
Phone
+380 50 384 70 48
Facility Name
Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2
City
Kyiv
ZIP/Postal Code
08631
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional clinical Psychiatric Hospital, Department #20
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kateryna Zakal
Phone
+380677672919
Facility Name
Communial Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuriy Filts, MD
Phone
+380322954900
Facility Name
2-A Metalurgiv street
City
Nove
ZIP/Postal Code
25491
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yevgen Denysov, MD
Phone
+38-050-564-10-35
Facility Name
Communal Non-commercial Enterprise Odesa Regional Medical Center of Mental Health of Odesa Regional Council, Department #6 (male), Department #12 (female)
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anatolii Voloshchuk
Phone
+380637356555
Facility Name
Communal Institution Odesa Regional Psychiatric Hospital #2, Department #14 (female), Department #16 (male)
City
Odesa
ZIP/Postal Code
67513
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oleksandr Mykhaylyukovych, MD
Phone
+380677550464
Facility Name
Communal Institution O.I. Yushchenko Vinnytsia Regional Psychoneurological Hospital, Female Department #10, Male Department #7, Vinnytsia M.I.Pyrogov National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Education
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofiia Rymsha, MD
Phone
+38 067-936-03-38
Facility Name
Communal Institution O.I.Yushchenko Vinnytsia Regional Psychoneurological Hospital, Male Department #21, Female Department #15, M.I. Pyrogov Vinnytsia National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Educatio
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study may be made available upon request via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available upon request within 12 months of posting the study results on ct.gov.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com
Learn more about this trial
A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
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