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COMPLETEDPHASE4

Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

A Phase 4, Multicenter, Open-label, Interventional Trial to Assess the Effects on Engagement of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy for the Treatment of Adults With Major Depressive Disorder

NCT04830215•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

The clinical trial will investigate the effect of brexpiprazole on the concept of life engagement in participants with Major Depressive Disorder (MDD) with a current depressive episode.

Detailed Description

This is a phase 4, multicenter, open-label, flexible dose trial designed to assess the effects of brexpiprazole (flexible dose; 0.5 to 2 milligrams \[mg\], once daily \[QD\]) as adjunctive therapy to antidepressant therapy (ADT) on life engagement in participants with MDD. This trial is being conducted in line with the Canadian Product Monograph.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent.
•Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs in their current MDE, including current ADT.
•Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate.

Exclusion Criteria

•Participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial.
•Participants with a concurrent DSM-5 diagnosis of the following will be excluded:
•* Schizophrenia or schizoaffective disorder
•* Bipolar I or bipolar II disorder
•* Post-traumatic stress disorder
•* Dementia
•* Eating disorder
•* Borderline personality disorder
•* Antisocial personality disorder
•Participants with a suicidality score of 3 based on Inventory of Depressive Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the opinion of the investigator, presents a serious risk of suicide.

Locations (1)

Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, Canada

Key Dates

Start Date

April 1, 2021

Primary Completion Date

May 27, 2022

Completion Date

May 27, 2022

Last Updated

February 2, 2024

Enrollment

122

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Brexpiprazole

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

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Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression