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

Study Identifier:
331-201-00376
ClinicalTrials.gov Identifier:
NCT05504486
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Terminated/Withdrawn
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Study Details

Medical Condition
  • Depression
Study Drug
  • Drug: Brexpiprazole
Date
Aug 2022 - Mar 2023
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
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

Protocol 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.

Study Locations

No locations found.
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
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

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