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A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SEP363856
quetiapine XR
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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

The main inclusion criteria include, but are not limited to the following:

  • Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
  • Subject meets DSM-5 criteria for a diagnosis of schizophrenia as established by clinical interview at screening (using the DSM-5 as a reference and confirmed using the SCID-CT). The time since the subject's diagnosis must be ≥ 1 year prior to Screening.
  • Subject must have a CGI-S score ≤ 4 at Screening and Baseline.
  • Subject must have a PANSS total score ≤ 80 at Screening and Baseline.
  • Subject is judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Screening.
  • Subject has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening.
  • Subjects taking an antipsychotic agent at Screening may participate in this study only if there are signs of intolerability or lack of efficacy of the current antipsychotic (as determined by the Investigator).
  • Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, PE, neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values (hematology, chemistry and urinalysis).

Exclusion criteria:

Main exclusion criteria include, but are not limited to:

  • Subject was hospitalized for a psychiatric illness within the 8 weeks prior to Screening.
  • Subject has a current 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, schizoaffective disorder, ,bipolar I or II disorder, obsessive compulsive disorder, and posttraumatic stress disorder, symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as theses symptoms are not the primary focus of treatment.
  • Subject is judged to be resistant to antipsychotic treatment by the Investigator, based on failure to respond to 2 or more marketed antipsychotic agents within a 1-year period prior to Screening, given at adequate dose as per labeling, for at least 4 weeks.
  • 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 Screening (i.e., in the past one month) or at Baseline (i.e., since last visit).
  • Subject is at significant risk of harming self or others based on Investigator's judgment.
  • Subject has attempted suicide within 6 months prior to Screening.
  • Subject has received treatment with a psychotropic medication or herbal supplement within 3 days or 5 half-lives (whichever is longer)
  • Subject has been treated with quetiapine or quetiapine XR within the 6 weeks prior to Screening or has a history of inadequate response or intolerability to quetiapine or quetiapine XR.
  • 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.
  • Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.

Sites / Locations

  • Synexus Clinical Research US, Inc.
  • Pacific Research Partners
  • Excell Research
  • Artemis Institute for Clinical Research
  • Collaborative Neuroscience Network
  • Innovative Clinical Research
  • Premier Clinical Research Institute
  • Synexus Clinical Research US
  • Alexian Brothers Center for Psychiatric Research
  • Pillar Clinical Research
  • Louisiana Clinical Research
  • PsychCare Consultants Research
  • Dean-Yurie, Altea Research
  • Krzsztof Wroblewi-Neurobehavioral Research Inc.
  • Tyne Moeller-Synexus Clinical Research US Inc.
  • Finger Lakes Clinical Research
  • New Hope Clinical Research
  • Dr. Shishuka Malhorta
  • Spitalul de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinica III, Str. Mihai Eminescu,
  • Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila", Sectia Psihiatrie
  • Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Sectia Psihiatrie XII
  • Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian",
  • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Sectia Clinica Psihiatrie XIII
  • Institutul de Psihiatrie Socola Iasi
  • State Budgetary Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
  • State Budgetary Institution of Heathcare of Sverdlovsk Region "Sverdlovsk Regional Clinical Psychiatric Hospital"
  • Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko"
  • State Budgetary Healthcare Institution of Moscow Region "Central Clinical Psychiatric Hospital"
  • Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital n.a. N.N. Solodovnikov"
  • Saint Petersburg State Public Institution of Healthcare "Psychiatric Hospital of Saint Nikolai Chudotvorets"
  • Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF
  • Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev"
  • Saint Petersburg State Budgetary Institution of Healthcare "City Psychoneurological Dispensary #5"
  • Saint Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensay No 1"
  • FSBEI HE "Smolensk State Medical University" of the MoH of the RF leg add: 28, Krupskoi str, Smolensk, Smolensk region, 214019; act add: 46-a, Kirova str, Smolensk
  • S St-Petersburg state budget institution Psychoneurological dispensary #10
  • State Budgetary Institution of Healthcare of Stavropol territory "Regional Specialization Psychiatry Hospital # 2"
  • LLC "Clinic Stolet" 30, Derbyshevskiy lane, Tomsk, Tomsk region, 634009, Russia based on FSBSI "Tomsk National Research Medical Center of Russian Academy of Sciences"
  • State Budgetary Institution of Healthcare of Yaroslavl region "Yaroslavl Regional Clinical Psychiatric Hospital"
  • Communal Non-commercial Enterprise Carpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council, Department of Neuroses and Edge Conditions/States #8
  • State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Clinical, Social and Child Psychiatry
  • State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency Psychiatry and Narcology
  • Kyiv Clinical Hospital on Railway Transport #2 of Healthcare Center branch of JSC "Ukrainian Railway", Consultative and Diagnostic Center of Policlinic
  • Communal Noncommercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
  • Communal Non-commercial Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council, Department of Psychiatry #2 (male), Department of Psychiatry #6 (female), Ternopil I.Ya. Gorbachevskyi National Medical University of t
  • Communal Noncommercial Enterprise Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions of Transcarpathian Regional Council, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SEP363856

quetiapine XR

Arm Description

SEP363856 50mg, 75mg, 100mg, flexibly dosed once daily capsule

quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule

Outcomes

Primary Outcome Measures

The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation

Secondary Outcome Measures

Full Information

First Posted
October 2, 2019
Last Updated
February 15, 2023
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04115319
Brief Title
A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
Official Title
A Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (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
Yes

5. Study Description

Brief Summary
A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia. This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 50 study centers worldwide. The study will last approximately 57 weeks.
Detailed Description
This is a 52-week, multicenter, randomized, double-blind, parallel-group, flexible-dose study designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day) compared with quetiapine XR (400 to 800 mg/day) in clinically stable adult subjects with schizophrenia. This study is projected to randomize a least 300 subjects to two treatment groups (SEP-363856 50 to 100 mg/day or quetiapine XR 400 to 800 mg/day) in a 2:1 ratio. Study drug will be taken once a day and may be taken without food or with a light meal.

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
Parallel Assignment
Model Description
A Randomized, Double-blind, Active Comparator-Controlled Study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
475 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEP363856
Arm Type
Experimental
Arm Description
SEP363856 50mg, 75mg, 100mg, flexibly dosed once daily capsule
Arm Title
quetiapine XR
Arm Type
Active Comparator
Arm Description
quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule
Intervention Type
Drug
Intervention Name(s)
SEP363856
Intervention Description
SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule
Intervention Type
Drug
Intervention Name(s)
quetiapine XR
Other Intervention Name(s)
Seroquel XR
Intervention Description
quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule
Primary Outcome Measure Information:
Title
The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation
Time Frame
52 Weeks

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: The main inclusion criteria include, but are not limited to the following: Male or female subject between 18 to 65 years of age (inclusive) at the time of consent. Subject meets DSM-5 criteria for a diagnosis of schizophrenia as established by clinical interview at screening (using the DSM-5 as a reference and confirmed using the SCID-CT). The time since the subject's diagnosis must be ≥ 1 year prior to Screening. Subject must have a CGI-S score ≤ 4 at Screening and Baseline. Subject must have a PANSS total score ≤ 80 at Screening and Baseline. Subject is judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Screening. Subject has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening. Subjects taking an antipsychotic agent at Screening may participate in this study only if there are signs of intolerability or lack of efficacy of the current antipsychotic (as determined by the Investigator). Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, PE, neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values (hematology, chemistry and urinalysis). Exclusion criteria: Main exclusion criteria include, but are not limited to: Subject was hospitalized for a psychiatric illness within the 8 weeks prior to Screening. Subject has a current 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, schizoaffective disorder, ,bipolar I or II disorder, obsessive compulsive disorder, and posttraumatic stress disorder, symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as theses symptoms are not the primary focus of treatment. Subject is judged to be resistant to antipsychotic treatment by the Investigator, based on failure to respond to 2 or more marketed antipsychotic agents within a 1-year period prior to Screening, given at adequate dose as per labeling, for at least 4 weeks. 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 Screening (i.e., in the past one month) or at Baseline (i.e., since last visit). Subject is at significant risk of harming self or others based on Investigator's judgment. Subject has attempted suicide within 6 months prior to Screening. Subject has received treatment with a psychotropic medication or herbal supplement within 3 days or 5 half-lives (whichever is longer) Subject has been treated with quetiapine or quetiapine XR within the 6 weeks prior to Screening or has a history of inadequate response or intolerability to quetiapine or quetiapine XR. 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. Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.
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
Synexus Clinical Research US, Inc.
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Pacific Research Partners
City
Oakland
State/Province
California
ZIP/Postal Code
94607
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Innovative Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Premier Clinical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Synexus Clinical Research US
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Pillar Clinical Research
City
Lincolnwood
State/Province
Illinois
ZIP/Postal Code
60712
Country
United States
Facility Name
Louisiana Clinical Research
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
PsychCare Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Dean-Yurie, Altea Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Krzsztof Wroblewi-Neurobehavioral Research Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Tyne Moeller-Synexus Clinical Research US Inc.
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Dr. Shishuka Malhorta
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Spitalul de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinica III, Str. Mihai Eminescu,
City
Brasov
ZIP/Postal Code
500079
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila", Sectia Psihiatrie
City
Brasov
ZIP/Postal Code
500079
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Sectia Psihiatrie XII
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Facility Name
Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian",
City
Bucuresti
ZIP/Postal Code
060222
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Sectia Clinica Psihiatrie XIII
City
Bucuresti
ZIP/Postal Code
41914,
Country
Romania
Facility Name
Institutul de Psihiatrie Socola Iasi
City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
State Budgetary Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
City
Arkhangelsk
ZIP/Postal Code
163530
Country
Russian Federation
Facility Name
State Budgetary Institution of Heathcare of Sverdlovsk Region "Sverdlovsk Regional Clinical Psychiatric Hospital"
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko"
City
Leningrad
ZIP/Postal Code
188357
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Moscow Region "Central Clinical Psychiatric Hospital"
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
Facility Name
Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital n.a. N.N. Solodovnikov"
City
Omsk
ZIP/Postal Code
644070
Country
Russian Federation
Facility Name
Saint Petersburg State Public Institution of Healthcare "Psychiatric Hospital of Saint Nikolai Chudotvorets"
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev"
City
Saint Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Saint Petersburg State Budgetary Institution of Healthcare "City Psychoneurological Dispensary #5"
City
Saint Petersburg
ZIP/Postal Code
195176
Country
Russian Federation
Facility Name
Saint Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensay No 1"
City
Saint Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
FSBEI HE "Smolensk State Medical University" of the MoH of the RF leg add: 28, Krupskoi str, Smolensk, Smolensk region, 214019; act add: 46-a, Kirova str, Smolensk
City
Smolensk
ZIP/Postal Code
214031
Country
Russian Federation
Facility Name
S St-Petersburg state budget institution Psychoneurological dispensary #10
City
St-Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of Stavropol territory "Regional Specialization Psychiatry Hospital # 2"
City
Stavropol
ZIP/Postal Code
357034
Country
Russian Federation
Facility Name
LLC "Clinic Stolet" 30, Derbyshevskiy lane, Tomsk, Tomsk region, 634009, Russia based on FSBSI "Tomsk National Research Medical Center of Russian Academy of Sciences"
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Facility Name
State Budgetary Institution of Healthcare of Yaroslavl region "Yaroslavl Regional Clinical Psychiatric Hospital"
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Communal Non-commercial Enterprise Carpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council, Department of Neuroses and Edge Conditions/States #8
City
Ivano-Frankivsk
ZIP/Postal Code
76011
Country
Ukraine
Facility Name
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Clinical, Social and Child Psychiatry
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency Psychiatry and Narcology
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Kyiv Clinical Hospital on Railway Transport #2 of Healthcare Center branch of JSC "Ukrainian Railway", Consultative and Diagnostic Center of Policlinic
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
City
Smila
ZIP/Postal Code
20708
Country
Ukraine
Facility Name
Communal Non-commercial Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council, Department of Psychiatry #2 (male), Department of Psychiatry #6 (female), Ternopil I.Ya. Gorbachevskyi National Medical University of t
City
Ternopil
ZIP/Postal Code
46027
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions of Transcarpathian Regional Council, Department of Psychiatry
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine

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 Vivli Center for Global Clinical Data Research 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://vivli.org

Learn more about this trial

A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

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