Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-05-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brexpiprazole

Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, orally (PO), QD, and continued on the stable dose of ADT up to 8 weeks.

Group Type OTHER

Brexpiprazole

Intervention Type DRUG

Oral brexpiprazole tablets as adjunctive therapy to ADT

Interventions

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Brexpiprazole

Oral brexpiprazole tablets as adjunctive therapy to ADT

Intervention Type DRUG

Other Intervention Names

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OPC-34712

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No