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An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SEP-363856
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 Schizophrenia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator.

  • Subject has completed Study SEP361 201 through Week 4
  • Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201.
  • Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
  • Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration

Exclusion Criteria:

  • Subject answers "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 C-SSRS assessment at Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
  • Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 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) or breath alcohol test at Visit 7 of Study SEP361 201.
  • Subject is pregnant or lactating.
  • Subject is at high risk of non-compliance in the Investigator's opinion.
  • Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.

Sites / Locations

  • Woodland International research Group
  • CNRI-Los Angeles, LLC
  • UCSD Medical Center UCSD Department of Psychiatry
  • Atlanta Center for Medical Research
  • Kashinath Yadalam
  • Pillar Clinical Research, LLC
  • Bugát Pál Kórház-Rendelőintézet, Rehabilitációs Elmegyógyászati Osztály
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Pszichiatriai Osztaly
  • Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
  • Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri "Sf. Stelian", Sectia Psihiatrie
  • spitalul Clinic de Neuropsihiatrie Craiova ,Clinica II Psihiatrie
  • Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti
  • Sverdlov Regional Psychiatric Clinical Hospital
  • St-Petersburg SHI Psychiatrical hospital #1 n.a. Kaschenko
  • SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
  • SHI Regional Clinical Psychiatry Hospital of St. Sofia
  • FSBEI HE "Smolensk State Medical University" of the MoH of the RF
  • City Psychiatric Hospital of St. Nikolay Chudotvorets
  • FB=SBI"Saint Petersburg Scientific and Research Psychoneurological Institute n.a. V.M. Bekhterev"
  • SPb SBIH "City Psychoneurological Dispensary #7 (with inpatient facilities)"
  • Regional Psychoneurological Hospital #3, Dept of Crisis Cond & Primary Psych Episode #1
  • CHI Kharkiv RCPH#3 Center of Emerg PsychSI Inst of Neur, Psych & Narc of NAMSU, Unit of Emergency Psychiatry and Narcology
  • CHI Kharkiv Regional Clinical Psychiatric Hospital #3, Psychiatric Department of Primary Psychotic Episod
  • CI Kherson Regional Psychiatric Hospital of Kherson RC
  • TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions
  • CI Odesa Regional Medical Center of Mental Health
  • CI Cherkasy Regional Psychiatric Hospital of ChRC, Femail Dept #11, Male Dept #12
  • Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #6 Ternopil I.ya. Gorbachevskyi SMU
  • Transcarpathian Regional Narcological Dispensary
  • CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SEP-363856

Arm Description

SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily

Outcomes

Primary Outcome Measures

The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation
Number of Participants with overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation

Secondary Outcome Measures

Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
Number of participants with suicidal ideation (SI) and suicidal behavior (SB) using the Columbia - Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
Time to Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856
Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others.
Rate of Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856
Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others.
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
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.
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score
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.
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score
The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form.
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms. Total score will be equal to the sum of the 10 items (range between 0 and 60).
Proportion of Subjects Who Achieved a Response, Defined as a 20% or Greater Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score From Double-blind Baseline of Study SEP361-201
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.

Full Information

First Posted
November 17, 2016
Last Updated
February 8, 2022
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02970929
Brief Title
An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
Official Title
A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
January 29, 2019 (Actual)
Study Completion Date
January 29, 2019 (Actual)

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
No

5. Study Description

Brief Summary
An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia
Detailed Description
This is a 26 week, multiregional, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 for the treatment of subjects with schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201 (NCT02969382) Subjects received open-label SEP-363856 50 mg/day from Day 1 through Day 3, and then received flexible dosing of SEP-363856 (25, 50, or 75 mg/day) for the rest of the trial. No statistical hypothesis tests will be performed.

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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEP-363856
Arm Type
Experimental
Arm Description
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
Intervention Type
Drug
Intervention Name(s)
SEP-363856
Intervention Description
One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks
Primary Outcome Measure Information:
Title
The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation
Description
Number of Participants with overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation
Time Frame
From first dose of study drug to last study visit (27 weeks)
Secondary Outcome Measure Information:
Title
Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
Description
Number of participants with suicidal ideation (SI) and suicidal behavior (SB) using the Columbia - Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
Time Frame
Overall post Open-label Baseline treatment period (26 weeks)
Title
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
Time Frame
Overall post Open-label Baseline treatment period (26 weeks)
Title
Time to Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856
Description
Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others.
Time Frame
From the time of clinical response to relapse or censor (one day after the last study drug dose)
Title
Rate of Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856
Description
Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others.
Time Frame
From the time of clinical response to relapse or censor (one day after the last study drug dose)
Title
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
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
Double-blind Baseline (DB BLN), Open-label Baseline (OL BLN), Week 26 (Wk 26)
Title
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score
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
Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
Title
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score
Description
The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form.
Time Frame
Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
Title
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms. Total score will be equal to the sum of the 10 items (range between 0 and 60).
Time Frame
Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
Title
Proportion of Subjects Who Achieved a Response, Defined as a 20% or Greater Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score From Double-blind Baseline of Study SEP361-201
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
Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator. Subject has completed Study SEP361 201 through Week 4 Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201. Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test. Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration Exclusion Criteria: Subject answers "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 C-SSRS assessment at Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation. Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 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) or breath alcohol test at Visit 7 of Study SEP361 201. Subject is pregnant or lactating. Subject is at high risk of non-compliance in the Investigator's opinion. Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.
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
Facility Name
CNRI-Los Angeles, LLC
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
UCSD Medical Center UCSD Department of Psychiatry
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8229
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Kashinath Yadalam
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Bugát Pál Kórház-Rendelőintézet, Rehabilitációs Elmegyógyászati Osztály
City
Gyongyos
State/Province
Dózsa György
ZIP/Postal Code
út 20-22
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Pszichiatriai Osztaly
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
City
Bucuresti
ZIP/Postal Code
010825
Country
Romania
Facility Name
Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri "Sf. Stelian", Sectia Psihiatrie
City
Bucuresti
ZIP/Postal Code
060222
Country
Romania
Facility Name
spitalul Clinic de Neuropsihiatrie Craiova ,Clinica II Psihiatrie
City
Craiova
ZIP/Postal Code
200473
Country
Romania
Facility Name
Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti
City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Sverdlov Regional Psychiatric Clinical Hospital
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
St-Petersburg SHI Psychiatrical hospital #1 n.a. Kaschenko
City
Gatchina
ZIP/Postal Code
188357
Country
Russian Federation
Facility Name
SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
SHI Regional Clinical Psychiatry Hospital of St. Sofia
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Facility Name
FSBEI HE "Smolensk State Medical University" of the MoH of the RF
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
City Psychiatric Hospital of St. Nikolay Chudotvorets
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
FB=SBI"Saint Petersburg Scientific and Research Psychoneurological Institute n.a. V.M. Bekhterev"
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
SPb SBIH "City Psychoneurological Dispensary #7 (with inpatient facilities)"
City
St. Petersburg
ZIP/Postal Code
198020
Country
Russian Federation
Facility Name
Regional Psychoneurological Hospital #3, Dept of Crisis Cond & Primary Psych Episode #1
City
Ivano Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
CHI Kharkiv RCPH#3 Center of Emerg PsychSI Inst of Neur, Psych & Narc of NAMSU, Unit of Emergency Psychiatry and Narcology
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
CHI Kharkiv Regional Clinical Psychiatric Hospital #3, Psychiatric Department of Primary Psychotic Episod
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
CI Kherson Regional Psychiatric Hospital of Kherson RC
City
Kherson, Vil Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
CI Odesa Regional Medical Center of Mental Health
City
Odesa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
CI Cherkasy Regional Psychiatric Hospital of ChRC, Femail Dept #11, Male Dept #12
City
Smila
ZIP/Postal Code
20708
Country
Ukraine
Facility Name
Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #6 Ternopil I.ya. Gorbachevskyi SMU
City
Ternopil
ZIP/Postal Code
46020
Country
Ukraine
Facility Name
Transcarpathian Regional Narcological Dispensary
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

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