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

Otsuka Pharmaceutical Development & Commercialization, Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Major Depressive Disorder (MDD)

Interventions

BrexpiprazoleDRUG

Oral tablet; take once daily; target daily dose of 2 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in fMRI resting-state salience network community structure from baseline to post-treatment

Time frame: Week 6

Secondary Outcomes

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

Time frame: Week 6

Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.

Utilizing Jaccardized Czekanowski index

Time frame: Week 6

Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment.

Utilizing Jaccardized Czekanowski index

Time frame: Week 6

Data from ClinicalTrials.gov

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