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A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia | Clinical Trials | Clareo Health

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A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate SEP-363856 Physical Dependence in Adult Subjects With Schizophrenia

NCT05848700•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia. This study will be held in approximately 6 study sites in the United States. It will be accepting male and female participants age 18 years to 65 years. Participation will be up to approximately10 weeks.

Detailed Description

This is a double-blind, placebo-controlled, randomized withdrawal study comparing abrupt discontinuation of SEP-363856 (SEP-363856 switched to placebo) to continuous SEP-363856 treatment in male and female adult subjects with schizophrenia.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subject between 18 and 65 years of age (inclusive) at the time of informed consent.
•Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview (using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version \[SCID-CT\]).
•Subject must have a Clinical Global Impression-Severity Scale (CGI-S) score ≤ 4 (normal to moderately ill) at Screening and Day 1.
•Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness).
•Subject has been taking an antipsychotic for at least 6 weeks prior to Screening and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes may be permitted) for at least 6 weeks prior to Screening.

Exclusion Criteria

•Subject has a DSM-5 diagnosis or presence of symptoms consistent with a current DSM-5 diagnosis other than schizophrenia.
•Subject has attempted suicide within 6 months prior to Screening.
•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 Columbia Suicide Severity Rating Scale (C-SSRS) at Screening (ie, in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
•Subject is at significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.

Locations (7)

Woodland International Research Group, LLC

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

Behavioral Clinical Research, Inc

Miami Lakes, Florida, United States

Research Centers of America at Fort Lauderdale Behavioral Health Center

Oakland Park, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Neuro-Behavioral Clinical Research, Inc

North Canton, Ohio, United States

Pillar Clinical Research, LLC

Richardson, Texas, United States

Key Dates

Start Date

June 21, 2023

Primary Completion Date

March 15, 2024

Completion Date

March 15, 2024

Last Updated

June 26, 2024

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

SEP-363856

DRUG

Placebo

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia

Inclusion Criteria

Exclusion Criteria

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