NCT05848700

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SEP-363856	SEP-363856 Tablet
DRUG	Placebo	Placebo Tablet

Timeline

• Start date: 2023-06-21
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2023-05-08
• Last updated: 2024-06-26

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study