Schizophrenia Clinical Trial
Official title:
A Randomized, Open-Label, Single Dose, Cross-over Study of Gastric Emptying Rate: SEP-363856 vs Prior Antipsychotic Standard of Care in Subjects With Schizophrenia
Verified date | December 2023 |
Source | Sumitomo Pharma America, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | September 27, 2023 |
Est. primary completion date | September 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Galiz Research | Hialeah | Florida |
United States | Woodland International Research Group | Little Rock | Arkansas |
United States | Collaborative Neuroscience Research, LLC | Long Beach | California |
United States | Research Centers of America | Oakland Park | Florida |
United States | Pillar Clinical Research LLC | Richardson | Texas |
United States | Woodland Research Northwest, LLC | Rogers | Arkansas |
United States | CNRI - San Diego, LLC | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Sumitomo Pharma America, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastric emptying T 1/2 (gastric emptying scintigraphy (GES) imaging) | 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. | multiple time-points post-radiolabelled meal on dosing day 1 and 2 | |
Primary | Gastric retention at 4 hr post-radiolabeled meal (gastric emptying scintigraphy (GES) imaging) | 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. | 4 hours post-radiolabel meal on dosing Day 1 and 2 | |
Secondary | Gastric retention (proportion retained or % retained) at 1 hr and 2 hr post-radiolabeled meal | Gastric retention (proportion retained or % retained) at 1h and 2h post meal. | 1 and 2 hours post-radiolabel meal |
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