Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04830215

Collaborator

Lundbeck Canada Inc. (Industry), Otsuka Canada Pharmaceutical Inc. (Industry)

122

Enrollment

Location

Arm

13.8

Actual Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Brexpiprazole	Phase 4

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Actual Primary Completion Date :

May 27, 2022

Actual Study Completion Date :

May 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Brexpiprazole 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 Brexpiprazole (flexible dose; 0.5 to 2 mg once daily [QD]) as adjunctive therapy to antidepressant therapy (ADT) Other Names: OPC-34712

Arm

Intervention/Treatment

Other: Brexpiprazole

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

Brexpiprazole (flexible dose; 0.5 to 2 mg once daily [QD]) as adjunctive therapy to antidepressant therapy (ADT)

Other Names:

OPC-34712

Outcome Measures

Primary Outcome Measures

Inventory of Depressive Symptomatology Self-Report (IDS-SR) 10-life engagement [Change from baseline to Week 8]
Change from baseline to Week 8 in IDS-SR-10- life engagement
Inventory of Depressive Symptomatology Self-Report (IDS-SR) Total score [Change from baseline to Week 8]
Change from baseline to Week 8 in IDS-SR Total score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.