A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia

• Status: Not yet recruiting
• Trial end date: 2023-10-23
• Target enrollment: 0
• Participant gender: All

Summary

A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia, and assess wether it affectsbody-weight associated parameters. This study is accepting male and female participants age 18 years to 65 years. This study will be conducted in approximately 6 study sites in the United States. Participation could last up to 13 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Antipsychotic Agents; Aripiprazole; Olanzapine; Quetiapine Fumarate; Risperidone

Criteria

Inclusion Criteria: This is not an all inclusive list

• Male or female subjects between 18 and 65 years of age, inclusive at time of 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 Positive and negative symptoms scale (PANSS) total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)

• Subject must have a Clinical Global Impressions - Severity (CGI-S) score ≤ 4 (normal to moderately ill) at Screening.

• Subject must be receiving risperidone, olanzapine, quetiapine or aripiprazole as treatment for schizophrenia at the time of Screening.

Exclusion Criteria: This is not an all inclusive list

• Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ < 70).

• Subject has attempted suicide within 12 months prior to Screening.

• Subject answers "yes" to "Suicidal Ideation" Items 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 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 risk of harming him/herself or others according to the Investigator's judgment.