Schizophrenia Clinical Trial
Official title:
A Double-Blind, Randomized, Multiple Dose Study of Weight Associated Parameters: SEP-363856 vs Prior Antipsychotic (PA) Standard of Care in Subjects With Schizophrenia Suffering From Metabolic Dysregulation
Verified date | March 2024 |
Source | Sumitomo Pharma America, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | February 12, 2024 |
Est. primary completion date | February 12, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Midwest Clinical Research Center | Dayton | Ohio |
United States | Woodland International Research Group | Little Rock | Arkansas |
United States | Shari DeSilva | Rogers | Arkansas |
United States | Endeavor Clinical Trials | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Sumitomo Pharma America, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insulin stimulated change in glucose disposal rate during the steady state of the low dose hyperinsulinemic euglycemic clamp (HEC), baseline to end of the treatment | up to 8 weeks | ||
Primary | Insulin stimulated change in glucose disposal rate during the steady state of the high dose hyperinsulinemic euglycemic clamp (HEC) baseline to end of the treatment. | up to 8 weeks | ||
Primary | Change in liver proton density fat fraction (PDFF), baseline to end of the treatment | up to 8 weeks | ||
Primary | Change in fat content in muscles of interest, baseline to end of the treatment | up to 8 weeks | ||
Primary | Change in Liver Fibroinflammation, baseline to end of the treatment | up to 8 weeks | ||
Primary | Change in Liver Volume from baseline to end of treatment | up to 8 weeks |
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