Schizophrenia Clinical Trial
Official title:
An Open-Label, Fixed Sequence, Multiple Dose Study of Glucose and Insulin Associated Parameters: SEP-363856 vs Prior Antipsychotic (PA) Standard of Care in Subjects With Schizophrenia Suffering From Metabolic Dysregulation
Verified date | December 2023 |
Source | Sumitomo Pharma America, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia and assess whether it changes: - how the body processes (uses) glucose (blood sugar) - how much insulin the pancreas can make. Insulin is a hormone that lowers blood sugar levels in the body. The information from this study will help to understand any effect the study medication may have on how the body uses and stores glucose. This study is accepting both male and female subjects. It will be held in approximately 6 locations in the United States. Participation could last up to 12 weeks.
Status | Completed |
Enrollment | 15 |
Est. completion date | August 22, 2023 |
Est. primary completion date | August 22, 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, LLC | Little Rock | Arkansas |
United States | Collaborative Neuroscience Research, LLC | Long Beach | California |
United States | Catalina Research Institute LLC | Montclair | California |
United States | Neuro-Behavioral Clinical Research, Inc. | North Canton | Ohio |
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 | Change from baseline (PA) in oGTT derived plasma AUC0-120 min of glucose, insulin, c-peptide in oGTT to stable dose (SEP-363856) period assessment. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | ||
Primary | Change from baseline (PA) in mixed meal tolerance test (MMTT) derived plasma AUC0-240 min of glucose, insulin, c-peptide and ß-cell responsivity index to stable dose (SEP-363856) period assessment. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | ||
Secondary | Change from baseline (PA) in plasma AUC0-240 min and Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | ||
Secondary | Change in Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | ||
Secondary | Change in gastric emptying terminal elimination half-life (T1/2), baseline to stable dose (SEP-363856) period assessment. | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | ||
Secondary | Change in kPCD, baseline to stable dose (SEP-363856) period assessment | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | ||
Secondary | Change in the Visual Analog Scale (VAS) of fullness, hunger and satiety, baseline - repeat test (PA baseline to SEP-363856 stable dose period assessment) for all time points. | Visual Analog Scale (VAS) is on a scale of 0-100, higher represents higher pain intensity (higher score represents worse outcome). | PA Baseline and SEP-363856 Stable Dose Period (up to 48 days) | |
Secondary | Change in lag time, baseline to stable dose (SEP-363856) period assessment | PA Baseline and SEP-363856 Stalbe Dose Period (up to 48 days) |
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