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

Sponsor ID
331-201-00376
Clinicaltrials.gov ID
NCT05504486
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Terminated/Withdrawn
Sponsor ID
331-201-00376
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Depression
    • Sex
    Female & Male
    Trial Dates
    Aug 2022 - Mar 2023
    Healthy Volunteers
    No
    • 18 to 65 year of age
    • Major Depressive Disorder (MDD) with symptoms of anxiety
    • Stable treatment with less than 50% improvement
    • Contraindicated to perform fMRI scan
    • Previous exposure to brexpiprazole

    Study 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.

    Additional Study Details

    Phase
    Phase 4
    Study Drug
    Drug: Brexpiprazole
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    N/A
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * 18 to 65 year of age
    • * Major Depressive Disorder (MDD) with symptoms of anxiety

    Exclusion Criteria

    • * Contraindicated to perform fMRI scan
    • * Previous exposure to brexpiprazole
    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

    Locations

    No locations found.

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