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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04115319
• Other study ID #: SEP361-304
• Secondary ID: 2019-002259-40
• Status: Completed
• Phase: Phase 3
• Start date: November 15, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2023
• Source: Sumitomo Pharma America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SEP363856
SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule
• quetiapine XR
quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule

Locations

Country	Name	City	State
Romania	Spitalul de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinica III, Str. Mihai Eminescu,	Brasov
Romania	Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila", Sectia Psihiatrie	Brasov
Romania	Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian",	Bucuresti
Romania	Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Sectia Psihiatrie XII	Bucuresti
Romania	Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Sectia Clinica Psihiatrie XIII	Bucuresti
Romania	Institutul de Psihiatrie Socola Iasi	Iasi
Russian Federation	State Budgetary Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"	Arkhangelsk
Russian Federation	State Budgetary Institution of Heathcare of Sverdlovsk Region "Sverdlovsk Regional Clinical Psychiatric Hospital"	Ekaterinburg
Russian Federation	Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko"	Leningrad
Russian Federation	State Budgetary Healthcare Institution of Moscow Region "Central Clinical Psychiatric Hospital"	Moscow
Russian Federation	Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital n.a. N.N. Solodovnikov"	Omsk
Russian Federation	Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev"	Saint Petersburg
Russian Federation	Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF	Saint Petersburg
Russian Federation	Saint Petersburg State Budgetary Institution of Healthcare "City Psychoneurological Dispensary #5"	Saint Petersburg
Russian Federation	Saint Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensay No 1"	Saint Petersburg
Russian Federation	Saint Petersburg State Public Institution of Healthcare "Psychiatric Hospital of Saint Nikolai Chudotvorets"	Saint Petersburg
Russian Federation	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	Smolensk
Russian Federation	S St-Petersburg state budget institution Psychoneurological dispensary #10	St-Petersburg
Russian Federation	State Budgetary Institution of Healthcare of Stavropol territory "Regional Specialization Psychiatry Hospital # 2"	Stavropol
Russian Federation	LLC "Clinic Stolet" 30, Derbyshevskiy lane, Tomsk, Tomsk region, 634009, Russia based on FSBSI "Tomsk National Research Medical Center of Russian Academy of Sciences"	Tomsk
Russian Federation	State Budgetary Institution of Healthcare of Yaroslavl region "Yaroslavl Regional Clinical Psychiatric Hospital"	Yaroslavl
Ukraine	Communal Non-commercial Enterprise Carpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council, Department of Neuroses and Edge Conditions/States #8	Ivano-Frankivsk
Ukraine	State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Clinical, Social and Child Psychiatry	Kharkiv
Ukraine	State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency Psychiatry and Narcology	Kharkiv
Ukraine	Kyiv Clinical Hospital on Railway Transport #2 of Healthcare Center branch of JSC "Ukrainian Railway", Consultative and Diagnostic Center of Policlinic	Kyiv
Ukraine	Communal Noncommercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12	Smila
Ukraine	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	Ternopil
Ukraine	Communal Noncommercial Enterprise Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions of Transcarpathian Regional Council, Department of Psychiatry	Uzhgorod
United States	Synexus Clinical Research US	Atlanta	Georgia
United States	Krzsztof Wroblewi-Neurobehavioral Research Inc.	Cedarhurst	New York
United States	Synexus Clinical Research US, Inc.	Cerritos	California
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Tyne Moeller-Synexus Clinical Research US Inc.	Jamaica	New York
United States	Dean-Yurie, Altea Research	Las Vegas	Nevada
United States	Pillar Clinical Research	Lincolnwood	Illinois
United States	Premier Clinical Research Institute	Miami	Florida
United States	Innovative Clinical Research	Miami Lakes	Florida
United States	Dr. Shishuka Malhorta	North Canton	Ohio
United States	Pacific Research Partners	Oakland	California
United States	Excell Research	Oceanside	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Louisiana Clinical Research	Shreveport	Louisiana
United States	Collaborative Neuroscience Network	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma America, Inc.

Countries where clinical trial is conducted

United States,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation		52 Weeks