Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-02-17 @ 5:41 PM
Study NCT ID:
NCT02334904
Status:
UNKNOWN
Last Update Posted:
2016-06-01
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
Comparison of Aripiprazole Versus Risperidone on Brain Morphology Using MRI
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARB
Brief Summary:
Significant changes in brain morphology are observed in people with first-episode psychosis. Studies have shown that total brain volume and particular brain structures are decreased in people with psychosis disorders. Recent evidence suggests that some atypical antipsychotic drugs can maintain or increase brain volumes. Thus, we plan to use MRI scans to measure changes in brain morphology in subjects recently diagnosed with bipolar or psychosis disorders who are taking the atypical antipsychotic drugs aripiprazole or risperidone. Secondary objectives include taking blood samples for fasting metabolic indices and neuropsychiatric measures for comparisons between drug treatments.
Detailed Description:
The purpose of this study is to use a direct measure of brain volume and matter (by means of MRI) to determine if there is a differential effect between aripiprazole and risperidone on brain morphology in participants with first-episode psychosis. A secondary objective is to see if fasting metabolic indices measured in the blood (i.e. glucose, insulin, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, adiponectin and leptin) are also correlated to changes in brain morphology or symptom severity (as measured by neuropsychiatric assessments).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: