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NCT05504486 Clinical Trial

Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety

Major Depressive Disorder (MDD) Clinical Trial

Official title:
A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT05504486
Other study ID # 331-201-00376
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date August 29, 2022
Est. completion date April 5, 2023

Study information
Verified date January 2023
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 5, 2023
Est. primary completion date March 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Brexpiprazole
Oral tablet; take once daily; target daily dose of 2 mg

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc. H. Lundbeck A/S

Outcome
Type Measure Description Time frame Safety issue
Primary Change in fMRI resting-state salience network community structure from baseline to post-treatment Week 6
Secondary Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment. Utilizing Jaccardized Czekanowski index Week 6
Secondary Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment. Utilizing Jaccardized Czekanowski index Week 6
Secondary Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment. Utilizing Jaccardized Czekanowski index Week 6
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