Schizophrenia
Conditions
Keywords
schizophrenia
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. 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.
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 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.
Interventions
DRUGSEP-363856
SEP-363856 will be supplied by 25 mg and 50 mg 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
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
(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 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). * 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 | Description |
|---|---|---|
| Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging) | multiple time-points post-radiolabelled meal on dosing day 1 and 2 | Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging) is gastric emptying half life (T1/2), which is a time needed for the half of the ingested gastric solids to leave the stomach. |
| Gastric retention at 4 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging) | 4 hours post-radiolabel meal on dosing Day 1 and 2 | Gastric retention at 4 hr post-radiolabeled meal is gastric retention 4h post meal, which estimates a percentage of remaining gastric solids in the stomach 4 hours after the meal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric retention (proportion retained or % retained) at 1 hr and 2 hr post-radiolabeled meal | 1 and 2 hours post-radiolabel meal | Gastric retention (proportion retained or % retained) at 1h and 2h post meal. |
Countries
United States
Outcome results
None listed