Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

Study Overview
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Brief Summary
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The clinical trial will investigate the effect of brexpiprazole on the concept of life engagement in patients with MDD with a current depressive episode.

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 mg QD) as adjunctive therapy to ADT on life engagement in patients with MDD. This trial is being conducted in line with the Canadian Product Monograph.

Official Title
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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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Brexpiprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients (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 MDE as defined by 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. Patients with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate. Exclusion Criteria: Patients currently or previously treated with brexpiprazole including patients who received brexpiprazole in any prior clinical trial. Patients 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 Patients with a suicidality score of 3 based on IDS-SR suicidality item 18 or patients who, in the opinion of the investigator, presents a serious risk of suicide.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Brexpiprazole<br>Brexpiprazole as a flexible dose; 0.5 to 2 mg/day and patient will continue on the stable dose of ADT that they were taking at screening. | Drug: Brexpiprazole<br>* Brexpiprazole (flexible dose; 0.5 to 2 mg once daily [QD]) as adjunctive therapy to antidepressant therapy (ADT)<br>* Other names: OPC-34712;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inventory of Depressive Symptomatology Self-Report (IDS-SR) 10-life engagement | Change from baseline to Week 8 in IDS-SR-10- life engagement | Change from baseline to Week 8 | 
| Inventory of Depressive Symptomatology Self-Report (IDS-SR) Total score | Change from baseline to Week 8 in IDS-SR Total score | Change from baseline to Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDD, Depression, Brexpiprazole