NCT05504486

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

August 29, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

May 31, 2022

Last Update Submit

January 26, 2023

Conditions

Major Depressive Disorder (MDD)

Keywords

Major depressive disorder (MDD)symptoms of anxietyfMRIbrain networksmodularitycommunity structurebrexpiprazoledefault mode networksalience networkcentral executive networkfunctional brain connectivity

Outcome Measures

Primary Outcomes (1)

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

    Week 6

Secondary Outcomes (3)

  • Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment.

    Week 6

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

    Week 6

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

    Week 6

Study Arms (1)

Arm 1

EXPERIMENTAL

Brexpiprazole

Drug: Brexpiprazole

Interventions

BrexpiprazoleDRUG

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

Arm 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 year of age
  • Major Depressive Disorder (MDD) with symptoms of anxiety
  • Stable treatment with less than 50% improvement

You may not qualify if:

  • Contraindicated to perform fMRI scan
  • Previous exposure to brexpiprazole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

August 17, 2022

Study Start

August 29, 2022

Primary Completion

March 22, 2023

Study Completion

April 5, 2023

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share