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A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SEP-363856 50mg
SEP-363856 75mg
Placebo
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring acute psychosis, schizophrenia

Eligibility Criteria

13 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
  2. Subject or subjects parent/legal guardian [adolescents] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..
  3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
  4. Subject must have a CGI-S score ≥ 4
  5. Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content
  6. Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
  7. Subject has marked deterioration of functioning in one or more areas.
  8. Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values.

Exclusion Criteria:

  1. Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months or lifetime history of significant substance abuse that in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact of the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
  2. Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
  3. Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study:
  4. Female subject who is pregnant or lactating
  5. Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.

Sites / Locations

  • Woodland International Research Group, LLC
  • Advanced Research Center, Inc.Recruiting
  • CITrialsRecruiting
  • Synergy San Diego
  • Alliance for Research
  • Catalina Research Institute
  • NRC Research Institute
  • NRC Research Institute
  • California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC)
  • UCSD Medical Center,UCSD Department of Psychiatry
  • Larkin Behavioral Health Services
  • Research Centers of America
  • South Florida Research Phase I-IV, Inc.Recruiting
  • Advanced Discovery Research LLCRecruiting
  • Advanced Discovery Research LLC
  • Atlantic Center for Medical ResearchRecruiting
  • iResearch Atlanta, LLCRecruiting
  • CBH Health, LLC
  • Precise Research Centers
  • Arch Clinical Trials, LLC
  • Clinical Research of Southern Nevada, LLCRecruiting
  • Midwest Clinical Research Center
  • Community Clinical Research
  • State Psychiatric Hospital - Pazardzhik AD-Department of Active Treatment of Men Department for Active Treatment of Woman Department of Active Treatment of Mean and Woman
  • UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic
  • Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders
  • UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry
  • UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry
  • First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector
  • Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders
  • Mental Health Center - Vratsa EOOD-Department of General Psychiatry
  • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE LtdaRecruiting
  • Centro de Investigaciones y Proyectos en Neurociencias CIPNARecruiting
  • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE LtdaRecruiting
  • State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1
  • State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"
  • SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"
  • State Budgetary Institution of Healthcare of nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod
  • FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12
  • State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital"
  • State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents
  • FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12
  • Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry
  • Clinical Center Nis, Center of Mental Health ProtectionRecruiting
  • Institute of Mental Health
  • Institute of Mental HealthRecruiting
  • Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39
  • Special Hospital for Psychiatric Diseases "Kovin",
  • Special Neuropsychiatric Hospital Kovin
  • Clinical Center Kragujevac, Clinic of Psychiatry
  • University Clinical Center Nis, Clinic of Psychiatry
  • Special Hospital for Psychiatric Diseases "SVeti Vracevi",
  • Clinical Center of Vojvodina, Clinic of Psychiatry
  • Special Hospital for Psychiatric Diseases
  • 15, Medychna St
  • 2-A Metalurgiv st
  • Dr. Vladyslav Demchenko
  • 103 Kyrylivska St
  • Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25
  • 9 Academician Vorobiov St
  • 1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region
  • 1 Medychna St
  • Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
  • Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SEP-363856 50mg

SEP-363856 75mg

Placebo

Arm Description

SEP-363856 50mg dosed once daily

SEP-363856 75mg dosed once daily

Placebo dosed once daily

Outcomes

Primary Outcome Measures

Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6)
PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.

Secondary Outcome Measures

Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6)
The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.

Full Information

First Posted
August 26, 2019
Last Updated
April 10, 2023
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04072354
Brief Title
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Official Title
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
June 8, 2023 (Anticipated)
Study Completion Date
June 8, 2023 (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
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 70 locations worldwide. The study will last up to 9 weeks total time.
Detailed Description
This is a multicenter, randomized, double-blind, parallel-group, fixed-dosed study evaluating the efficacy and safety of two doses of SEP-363856 (50 and 75 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 435 subjects (18-65 years) to 3 treatment groups (SEP-363856 50 mg/day, SEP-363856 75 mg/day, or placebo) in a 1:1:1 ratio. In addition, the study will randomize approximately 90 adolescent subjects (13-17 years) in a 1:1:1 ratio to the 3 treatment groups (with approximately 30 subjects per group) in a separate cohort. Treatment assignment will be stratified by country. Study drug will be taken once a day and may be taken with or without food. This study is designed to test the hypothesis that, treatment with SEP-363856 in adult subjects with schizophrenia will result in significantly greater reduction (i.e. improvement) in PANSS total score and CGI-S score at Week 6 from Baseline when compared to placebo. The overall Type I error is controlled for two hierarchical families of hypotheses. The first family includes hypotheses about the testing of change from Baseline in PANSS total score at Week 6 between each of the SEP-363856 dose levels vs. placebo. The second family of hypotheses are about the testing of change from Baseline in CGI-S score at Week 6 between each of the SEP-363856 dose levels vs. placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
acute psychosis, schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, parallel-group, placebo controlled, fixed-dose multicenter study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
525 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEP-363856 50mg
Arm Type
Experimental
Arm Description
SEP-363856 50mg dosed once daily
Arm Title
SEP-363856 75mg
Arm Type
Experimental
Arm Description
SEP-363856 75mg dosed once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dosed once daily
Intervention Type
Drug
Intervention Name(s)
SEP-363856 50mg
Intervention Description
SEP-363856 50mg tablet dosed once daily
Intervention Type
Drug
Intervention Name(s)
SEP-363856 75mg
Intervention Description
SEP-363856 75mg tablet dosed once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet dosed once daily
Primary Outcome Measure Information:
Title
Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6)
Description
PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6)
Description
The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.
Time Frame
Baseline and Week 6

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: Male or female subject between 13 to 65 years of age (inclusive) at the time of consent. Subject or subjects parent/legal guardian [adolescents] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent.. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening Subject must have a CGI-S score ≥ 4 Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent). Subject has marked deterioration of functioning in one or more areas. Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values. Exclusion Criteria: Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months or lifetime history of significant substance abuse that in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact of the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment. Subject is at significant risk of harming self, others, or objects based on Investigator's judgment. Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study: Female subject who is pregnant or lactating Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.
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
Sunovion Pharmaceuticals In.
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
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
CITrials
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Highum, MD
Phone
562-748-4999
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Alliance for Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Catalina Research Institute
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Withdrawn
Facility Name
California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC)
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UCSD Medical Center,UCSD Department of Psychiatry
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Larkin Behavioral Health Services
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Active, not recruiting
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
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
Advanced Discovery Research LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Atlantic Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Risenberg, MD
Ext
404-881-5800
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 Saundra Maass-Robinson, MD
Phone
404-537-1281
Facility Name
CBH Health, LLC
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Arch Clinical Trials, LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63125
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research of Southern Nevada, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Childress, MD
Phone
702-838-0742
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Community Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
State Psychiatric Hospital - Pazardzhik AD-Department of Active Treatment of Men Department for Active Treatment of Woman Department of Active Treatment of Mean and Woman
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector
City
Tsarev
ZIP/Postal Code
9747
Country
Bulgaria
Individual Site Status
Withdrawn
Facility Name
Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Mental Health Center - Vratsa EOOD-Department of General Psychiatry
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Active, not recruiting
Facility Name
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
City
Bogota
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo N Cordoba, MD
Phone
+57 601-3907122
Facility Name
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
City
Bogota
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
+57 601-3907122
Facility Name
State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Individual Site Status
Completed
Facility Name
State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"
City
Karelia
ZIP/Postal Code
186131
Country
Russian Federation
Individual Site Status
Completed
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
Completed
Facility Name
State Budgetary Institution of Healthcare of nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod
City
Nizniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Individual Site Status
Completed
Facility Name
FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Completed
Facility Name
State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital"
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Individual Site Status
Completed
Facility Name
State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Individual Site Status
Completed
Facility Name
FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12
City
St. petersburg
ZIP/Postal Code
092019
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Clinical Center Nis, Center of Mental Health Protection
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miodrag Stankovic
Phone
+381 691049501
Facility Name
Institute of Mental Health
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Active, not recruiting
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 Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39
City
Gornja Toponica
ZIP/Postal Code
18202
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Special Hospital for Psychiatric Diseases "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
Active, not recruiting
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
Active, not recruiting
Facility Name
Special Hospital for Psychiatric Diseases "SVeti Vracevi",
City
Novi Knezevac
ZIP/Postal Code
23330
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Clinical Center of Vojvodina, Clinic of Psychiatry
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Withdrawn
Facility Name
Special Hospital for Psychiatric Diseases
City
Vrsac
ZIP/Postal Code
26300
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
15, Medychna St
City
Ivano-Frankivsk
ZIP/Postal Code
76011
Country
Ukraine
Individual Site Status
Completed
Facility Name
2-A Metalurgiv st
City
Kropyvnytskyi
ZIP/Postal Code
25491
Country
Ukraine
Individual Site Status
Completed
Facility Name
Dr. Vladyslav Demchenko
City
Kyiv
ZIP/Postal Code
02192
Country
Ukraine
Individual Site Status
Completed
Facility Name
103 Kyrylivska St
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Individual Site Status
Completed
Facility Name
9 Academician Vorobiov St
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Individual Site Status
Completed
Facility Name
1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region
City
Odesa
ZIP/Postal Code
67513
Country
Ukraine
Individual Site Status
Completed
Facility Name
1 Medychna St
City
Poltava
ZIP/Postal Code
36013
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
City
Smila
ZIP/Postal Code
20708
Country
Ukraine
Individual Site Status
Completed
Facility Name
Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Individual Site Status
Completed

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 Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

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