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

NCT ID: NCT05504486

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-29

Study Completion Date

2023-04-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder (MDD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1

Brexpiprazole

Group Type EXPERIMENTAL

Brexpiprazole

Intervention Type DRUG

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

Interventions

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Brexpiprazole

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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331-201-00376

Identifier Type: -

Identifier Source: org_study_id

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