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

Primary Purpose

Major Depressive Disorder (MDD)

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brexpiprazole
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder (MDD) focused on measuring Major depressive disorder (MDD), symptoms of anxiety, fMRI, brain networks, modularity, community structure, brexpiprazole, default mode network, salience network, central executive network, functional brain connectivity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm 1

    Arm Description

    Brexpiprazole

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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
    Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.
    Utilizing Jaccardized Czekanowski index
    Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment.
    Utilizing Jaccardized Czekanowski index

    Full Information

    First Posted
    May 31, 2022
    Last Updated
    January 26, 2023
    Sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Collaborators
    H. Lundbeck A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05504486
    Brief Title
    Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Sponsor strategic decision
    Study Start Date
    August 29, 2022 (Anticipated)
    Primary Completion Date
    March 22, 2023 (Anticipated)
    Study Completion Date
    April 5, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Collaborators
    H. Lundbeck A/S

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder (MDD)
    Keywords
    Major depressive disorder (MDD), symptoms of anxiety, fMRI, brain networks, modularity, community structure, brexpiprazole, default mode network, salience network, central executive network, functional brain connectivity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Description
    Brexpiprazole
    Intervention Type
    Drug
    Intervention Name(s)
    Brexpiprazole
    Intervention Description
    Oral tablet; take once daily; target daily dose of 2 mg
    Primary Outcome Measure Information:
    Title
    Change in fMRI resting-state salience network community structure from baseline to post-treatment
    Time Frame
    Week 6
    Secondary Outcome Measure Information:
    Title
    Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment.
    Description
    Utilizing Jaccardized Czekanowski index
    Time Frame
    Week 6
    Title
    Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.
    Description
    Utilizing Jaccardized Czekanowski index
    Time Frame
    Week 6
    Title
    Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment.
    Description
    Utilizing Jaccardized Czekanowski index
    Time Frame
    Week 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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