Clinical trial
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
Name
SEP361-122
Description
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.
Trial arms
Trial start
2022-11-15
Estimated PCD
2024-02-12
Trial end
2024-02-12
Status
Completed
Phase
Early phase I
Treatment
SEP-363856
SEP-363856 will be supplied as over-encapsulated tablets. Multiple tablets may be required to achieve a single dose.
Arms:
SEP-363856
Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)
PA will be prepared by the pharmacy staff according to the patient's prescribed treatment and will be orally administered. Multiple tablets or capsules may be required to achieve a single dose.
Arms:
Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)
Size
19
Primary endpoint
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
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
Change in liver proton density fat fraction (PDFF), baseline to end of the treatment
up to 8 weeks
Change in fat content in muscles of interest, baseline to end of the treatment
up to 8 weeks
Change in Liver Fibroinflammation, baseline to end of the treatment
up to 8 weeks
Change in Liver Volume from baseline to end of treatment
up to 8 weeks
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-Blind, Randomized, Multiple Dose', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double Blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2024-03-29
1 organization
Organization
Sumitomo Pharma America