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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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