Status:
COMPLETED
A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
A clinical study to determine whether an investigational medication (SEP363856) changes how long it takes for food to move through the stomach into the small intestine in patients with schizophrenia. ...
Detailed Description
This is a randomized, open-label, single dose two-period crossover study with two treatment sequences. For each treatment sequence, subjects will receive a single-dose of SEP-363856 and prior antipsyc...
Eligibility Criteria
Inclusion
- (this list is not all inclusive)
- 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 CGI-S score ≤ 4 (normal to moderately ill) at Screening
- Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
- Subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the Screening visit.
Exclusion
- (this list is not all inclusive)
- 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.
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05402111
Start Date
June 13 2022
End Date
September 27 2023
Last Update
June 26 2024
Active Locations (7)
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1
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
2
Woodland Research Northwest, LLC
Rogers, Arkansas, United States, 72758
3
Collaborative Neuroscience Research, LLC
Long Beach, California, United States, 90806
4
CNRI - San Diego, LLC
San Diego, California, United States, 92102