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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
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.
Woodland International Research Group
Little Rock, Arkansas, United States
Shari DeSilva
Rogers, Arkansas, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
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
Time frame: 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.
Time frame: up to 8 weeks
Change in liver proton density fat fraction (PDFF), baseline to end of the treatment
Time frame: up to 8 weeks
Change in fat content in muscles of interest, baseline to end of the treatment
Time frame: up to 8 weeks
Change in Liver Fibroinflammation, baseline to end of the treatment
Time frame: up to 8 weeks
Change in Liver Volume from baseline to end of treatment
Time frame: up to 8 weeks
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