A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

Schizophrenia Clinical Trial

Official title:

An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05628103
• Other study ID #: SEP361-308
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 19, 2022
• Est. completion date: July 24, 2024

Study information

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

Clinical Trial Summary

A clinical study that will evalute how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants, ages of 18 years to 65 years, with schizophrenia. The study will take place in approxmiately 24 study sites in North America. Particpants should expect to be in the study for up to 12 weeks.

Description:

This is an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study designed to evaluate the safety and tolerability, as well as effectiveness of switching clinically stable adult subjects with schizophrenia from a typical or atypical antipsychotic to SEP-363856. This study is projected to enroll approximately 120 subjects into a single treatment group (SEP-363856).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 24, 2024
• Est. primary completion date: July 24, 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 to 65 years of age.
• Subject meets DSM-5 criteria for a diagnosis of schizophrenia.
• Subject is judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.
• Subject must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.
• Subject is taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening. Exclusion Criteria:This list is not all inclusive
• Subject has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
• Subject is at significant risk of harming self or others based on investigator's judgment.
• 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.
• Female subject who is pregnant or lactating.
• Subject tests positive for drugs of abuse at Screening.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SEP-363856
SEP-363856 flexibly dosed

Locations

Country	Name	City	State
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Advanced Discovery Research LLC	Atlanta	Georgia
United States	Atlanta Behavioral Research	Atlanta	Georgia
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Clinical Innovations Inc.	Bellflower	California
United States	Hassman Research Institute	Berlin	New Jersey
United States	New Hope Clinical Research	Charlotte	North Carolina
United States	Uptown Research	Chicago	Illinois
United States	ProScience Research Group	Culver City	California
United States	CBH Health	Gaithersburg	Maryland
United States	Collaborative Neuroscience Research, LLC	Garden Grove	California
United States	Charak Clinical Research Center	Garfield Heights	Ohio
United States	Clinical Trials of America, LLC	Hickory	North Carolina
United States	Larkin Behavioral Health Services	Hollywood	Florida
United States	Synergy San Diego	Lemon Grove	California
United States	Premier Clinical Research Institute, Inc.	Miami	Florida
United States	Wellness Research Center	Miami	Florida
United States	Nova Psychiatry, Inc.	Orlando	Florida
United States	Pillar Clinical Research, LLC	Richardson	Texas
United States	Clinical Innovations, Inc	Riverside	California
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)	San Diego	California
United States	CMB Clinical Trials	Santee	California
United States	Cenexel CNS Research	Torrance	California

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	Percentage of subjects who discontinue for clinical reasons (ie, discontinued due to an adverse event [AE] or lack of efficacy)		Up to Week 12
Secondary	Percentage of subjects who discontinue for any reason (ie, all causes for discontinuation)		Up to Week 12