Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05504486
Collaborator
H. Lundbeck A/S (Industry)
27
1
7.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
27 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date
:
Aug 29, 2022
Anticipated Primary Completion Date
:
Mar 22, 2023
Anticipated Study Completion Date
:
Apr 5, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 Brexpiprazole |
Drug: Brexpiprazole
Oral tablet; take once daily; target daily dose of 2 mg
|
Outcome Measures
Primary Outcome Measures
- Change in fMRI resting-state salience network community structure from baseline to post-treatment [Week 6]
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- H. Lundbeck A/S
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT05504486
Other Study ID Numbers:
- 331-201-00376
First Posted:
Aug 17, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.
Additional relevant MeSH terms: