Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
- Registration Number
- NCT05504486
- Brief Summary
The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 18 to 65 year of age
- Major Depressive Disorder (MDD) with symptoms of anxiety
- Stable treatment with less than 50% improvement
Exclusion Criteria
- Contraindicated to perform fMRI scan
- Previous exposure to brexpiprazole
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Brexpiprazole Brexpiprazole
- Primary Outcome Measures
Name Time Method Change in fMRI resting-state salience network community structure from baseline to post-treatment Week 6
- Secondary Outcome Measures
Name Time Method Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment. Week 6 Utilizing Jaccardized Czekanowski index
Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment. Week 6 Utilizing Jaccardized Czekanowski index
Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment. Week 6 Utilizing Jaccardized Czekanowski index