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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05848700
• Other study ID #: SEP361-121
• Status: Completed
• Phase: Phase 1
• Start date: June 21, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: March 2024
• Source: Sumitomo Pharma America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: (this list is not all inclusive)

• 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: (this list is not all inclusive)
• 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SEP-363856
SEP-363856 Tablet
• Placebo
Placebo Tablet

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Woodland International Research Group, LLC	Little Rock	Arkansas
United States	Behavioral Clinical Research, Inc	Miami Lakes	Florida
United States	Neuro-Behavioral Clinical Research, Inc	North Canton	Ohio
United States	Research Centers of America at Fort Lauderdale Behavioral Health Center	Oakland Park	Florida
United States	Pillar Clinical Research, LLC	Richardson	Texas
United States	Woodland Research Northwest	Rogers	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum change from the steady-state baseline (CSSBmax) in the total score of the 20 item Physician Withdrawal Checklist (PWC-20) during the 7-day Randomized Withdrawal Period		up to10 weeks