Schizophrenia
Conditions
Brief 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.
Detailed description
This is a double-blind, randomized, multiple dose study in male and female adult subjects with schizophrenia. Subjects will undergo structural magnetic resonance abdominal imaging (MRI) scans as well as hyperinsulinemic euglycemic clamp (HEC) also known as glucose clamp, after the check-in and towards the end of the treatment phase. Subjects will be randomized to SEP-363856 or their prior antipsychotic (PA). Subjects randomized to SEP-363856 will undergo blinded wash out of their PA, subsequent SEP-363856 blinded titration and 15 day of well tolerated SEP-363856 exposure. Subjects randomized to their prior antipsychotic (PA), will undergo pseudo PA washout, followed by pseudo-titration and 15 day of well tolerated PA exposure. Subjects will be discharged after subject is stable. All subjects will return to the clinic 7 + 2 days post discharge for follow-up assessments.
Interventions
DRUGSEP-363856
SEP-363856 will be supplied as over-encapsulated tablets. Multiple tablets may be required to achieve a single dose.
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.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind
Intervention model description
Double-Blind, Randomized, Multiple Dose
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed