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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Placebo; Drug: SEP-363856

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group, LLC
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • Behavioral Clinical Research, Inc
    • Oakland Park, Florida, United States, 33334
      • Research Centers of America at Fort Lauderdale Behavioral Health Center
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
  • Ohio
    • North Canton, Ohio, United States, 44720
      • Neuro-Behavioral Clinical Research, Inc
  • Texas
    • Richardson, Texas, United States, 75080
      • Pillar Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo Tablet
Experimental: SEP-363856	Drug: SEP-363856; SEP-363856 Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Investigators: Study Chair: CNS Medical Director, Sumitomo Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2023
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: SEP361-121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No