search
Back to results

A Clinical Trial That Will 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 75mg
SEP-363856 100mg
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

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

Inclusion Criteria:

  1. Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
  2. Subject must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.
  3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screeing.
  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 on 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 investigator.

Sites / Locations

  • Woodland International Research Group
  • Woodland Research Northwest
  • Advanced Research Center, Inc.Recruiting
  • Clinical Innovations, Inc.Recruiting
  • ProScience Research GroupRecruiting
  • Collaborative Neuroscience NetworkRecruiting
  • California Neuropsychopharmacology Clinical Research Institute
  • UCSD Medical Center UCSD Department of Psychiatry
  • Schuster Medical Research Institute
  • Larkin Behavioral Health ServicesRecruiting
  • South Florida Research Phase I-IV, INC.Recruiting
  • Atlanta Center for Medical ResearchRecruiting
  • iResearch Atlanta, LLCRecruiting
  • Pillar Clinical ResearchRecruiting
  • Lake Charles Clinical Trials
  • CBH Health, LLCRecruiting
  • Precise Research Centers
  • Arch Clinical Trials, LLCRecruiting
  • Hassman Research Institute
  • New York State Psychiatric Institute
  • Pillar Clinical ResearchRecruiting
  • Mental Health Centre, Prof. Dr. Ivan Temkov, Burgas EOOD, Department for Treatment of Emergency Psychiatric ConditionsRecruiting
  • State Psychiatric Hospital - Kardzhali, First Woman Department, Third Men Deparment
  • State Psychiatric Hospital Sv. Ivan rilski-Department General Psychiatry for Adults "closed" Type -Men, Department General Psychiatry for Adults, "Closed" Type - WomenRecruiting
  • UMHAT Sveti Georgi EADRecruiting
  • Mental Health Center - Sofia EOOD Unit for Active Treatment of Persons with Serious Mental DisordersRecruiting
  • UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of PsychiatryRecruiting
  • State Psychiatric Hospital - s. Tsarev brod First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector
  • University Hospital Centre Split
  • Polyclinic Neuron
  • Psychiatric Hospital "Sveti Ivan"Recruiting
  • University Psychiatric Hospital Vrapče
  • LTD Psychoeurological Hospital of DaugavpilsRecruiting
  • SLLC Riga Centre of Psychiatry and Narcology
  • SLLC Psychoneurological Hospital of StrenciRecruiting
  • State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"
  • State Healthcare Institution "Psychiatric Hospital of Engels" of MoH of Saratov Region, departments № 1 and 3, 166
  • State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
  • State Budgetary Institution of Healthcare of Moscow "Psychiatric Clinical Hospital #1 named after N.A. Alekseev of Department of Healthcare of Moscow
  • State Budgetary Institution of Healthcare of Moscow "Psychiatric Hospital No. 5"
  • Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko, inpatient No 2 leg add
  • FSBI- "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF3
  • Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov"
  • State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy" 20 and 21 departments
  • State Institution of Healthcare Regional Clinical Psychiatric Hospital of Saint Sofia
  • FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekterev" MoH RF
  • State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2"
  • Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of Russian Academy of Sciences",
  • Clinic of Psychiatry, Clinical Center of Serbia,Recruiting
  • Clinic of Psychiatry, Clinical Center of SerbiaRecruiting
  • Clinical Center "Dr Dragisa Misovic- Dedinje"Recruiting
  • Special Hospital for Psychiatric Diseases "Kovin"
  • Special Hospital for Psychiatric Diseases "Kovin"Recruiting
  • Special Neuropsychiatric Hospital Kovin
  • Clinic of Psychiatry, clinical Center KragujevacRecruiting
  • Clinic of Psychiatry, Clinical Center KragujevacRecruiting
  • University Clinical Center Kragujevac, Clinic of PsychiatryRecruiting
  • University Clinical Center Nis, Clinic of Psychiatry
  • Special Hospital for Psychiatric Disease Sveti VraceviRecruiting
  • Special Hospital for Psychiatric Diseases "SVeti Vracevi"Recruiting
  • Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"Recruiting
  • 46 Academician Pavlov St
  • State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry
  • Communica Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10
  • Kyev 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
  • Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2
  • Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4 ,
  • Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4
  • Communal Noncommercial Enterprise of Lviv Regional Concil Lviv Regional Clinical Psychiatric Hospital, Department #20
  • Communal Institution O.I. Yuschenko 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 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SEP-363856 75mg

SEP-363856 100mg

Placebo

Arm Description

SEP-363856 75mg dosed once daily

SEP-363856 100mg 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
September 13, 2019
Last Updated
March 19, 2023
Sponsor
Sumitomo Pharma America, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04092686
Brief Title
A Clinical Trial That Will 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
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 8, 2023 (Anticipated)
Study Completion Date
September 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 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.
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 (75 and 100 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 462 subjects to 3 treatment groups (SEP-363856 75 mg/day, SEP-363856 100 mg/day, or placebo) in a 1:1:1 ratio. 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 hypotheses 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
A randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
462 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEP-363856 75mg
Arm Type
Experimental
Arm Description
SEP-363856 75mg dosed once daily
Arm Title
SEP-363856 100mg
Arm Type
Experimental
Arm Description
SEP-363856 100mg dosed once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 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)
SEP-363856 100mg
Intervention Description
SEP-363856 100mg 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
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subject between 18 to 65 years of age (inclusive) at the time of consent. Subject must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screeing. 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 on 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 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
Sumitomo Pharma America, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Withdrawn
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
Phone
714-999-6688
Facility Name
Clinical Innovations, Inc.
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
Phone
562-748-4999
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
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
California Neuropsychopharmacology Clinical Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92102
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
Withdrawn
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodore Treese
Phone
305-722-8444
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
Atlanta 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 Riesenberg
Phone
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 Maass-Robinson
Phone
404-537-1281
Facility Name
Pillar Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60641
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roueen Rafeyan
Phone
224-534-7332
Facility Name
Lake Charles Clinical Trials
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Individual Site Status
Completed
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
Elia Acevedo Diaz, 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
Withdrawn
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
Active, not recruiting
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
Pillar Clinical Research
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Bartley, MD
Phone
214-396-4844
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
Ivan Temkov, MD
Phone
+359888451225
Facility Name
State Psychiatric Hospital - Kardzhali, First Woman Department, Third Men Deparment
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Individual Site Status
Active, not recruiting
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
Tsvetesiava Galabova, MD
Phone
+3599917215
Facility Name
UMHAT Sveti Georgi EAD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Popov, MD
Phone
+359888498975
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emil Grashnov, MD
Phone
+359 887 508 204
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
+359 888 941 451
Facility Name
State Psychiatric Hospital - s. Tsarev brod 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
University Hospital Centre Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Withdrawn
Facility Name
Polyclinic Neuron
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Withdrawn
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
University Psychiatric Hospital Vrapče
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Individual Site Status
Withdrawn
Facility Name
LTD Psychoeurological Hospital of Daugavpils
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inna Sapele
Phone
+37165402223
Facility Name
SLLC Riga Centre of Psychiatry and Narcology
City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Individual Site Status
Completed
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
+37164731340
Facility Name
State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"
City
Arkhangelsk
ZIP/Postal Code
163530
Country
Russian Federation
Individual Site Status
Completed
Facility Name
State Healthcare Institution "Psychiatric Hospital of Engels" of MoH of Saratov Region, departments № 1 and 3, 166
City
Engels
ZIP/Postal Code
413124
Country
Russian Federation
Individual Site Status
Completed
Facility Name
State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
City
Leningrad
ZIP/Postal Code
188820
Country
Russian Federation
Individual Site Status
Completed
Facility Name
State Budgetary Institution of Healthcare of Moscow "Psychiatric Clinical Hospital #1 named after N.A. Alekseev of Department of Healthcare of Moscow
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
Individual Site Status
Completed
Facility Name
State Budgetary Institution of Healthcare of Moscow "Psychiatric Hospital No. 5"
City
Moscow
ZIP/Postal Code
141371
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko, inpatient No 2 leg add
City
Saint Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Individual Site Status
Completed
Facility Name
FSBI- "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF3
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov"
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Completed
Facility Name
State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy" 20 and 21 departments
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Individual Site Status
Completed
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
Completed
Facility Name
FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekterev" MoH RF
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Completed
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
Completed
Facility Name
Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of Russian Academy of Sciences",
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Individual Site Status
Completed
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, PhD
Phone
+381641303993
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
Clinical Center "Dr Dragisa Misovic- Dedinje"
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Diligenski Diligenski, Prof.
Phone
+381 11 367 9200
Facility Name
Special Hospital for Psychiatric Diseases "Kovin"
City
Kovin
ZIP/Postal Code
26200
Country
Serbia
Individual Site Status
Withdrawn
Facility Name
Special Hospital for Psychiatric Diseases "Kovin"
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jovanka Petrovic
Phone
+38163529054
Facility Name
Special Neuropsychiatric Hospital Kovin
City
Kovin
ZIP/Postal Code
26220
Country
Serbia
Individual Site Status
Active, not recruiting
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
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, Professor
Phone
+38134300320
Facility Name
University Clinical Center Kragujevac, Clinic of Psychiatry
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Janjic, Prof.
Phone
+38134370151
Facility Name
University Clinical Center Nis, Clinic of Psychiatry
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Completed
Facility Name
Special Hospital for Psychiatric Disease Sveti Vracevi
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
Special Hospital for Psychiatric Diseases "SVeti Vracevi"
City
Novi Knezevac
ZIP/Postal Code
23330
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzana Stijovic, MD
Phone
+38163529049
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
46 Academician Pavlov St
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Completed
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
Completed
Facility Name
Communica 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
Completed
Facility Name
Kyev 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
Completed
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
Completed
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
Completed
Facility Name
Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4 ,
City
Kyiv
ZIP/Postal Code
08631
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4
City
Kyiv
ZIP/Postal Code
08631
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Concil Lviv Regional Clinical Psychiatric Hospital, Department #20
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Individual Site Status
Completed
Facility Name
Communal Institution O.I. Yuschenko 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
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 That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

We'll reach out to this number within 24 hrs