Status and phase
Conditions
Treatments
About
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. This study is accepting both male and female subjects. It will be conducted in approximately 6 study sites in the United States. The duration of participation will be approximtely 10 weeks.
Full 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 antipsychotic (PA) standard of care (PA) in random order. Up to 3 separate cohorts of subjects will be randomized to determine the final dose of SEP-363856.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria: (this list is not all inclusive)
Exclusion Criteria: (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).
Primary purpose
Allocation
Interventional model
Masking
31 participants in 2 patient groups
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Central trial contact
CNS Medical Director
Data sourced from clinicaltrials.gov
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