Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborators: Lundbeck Canada Inc.; Otsuka Canada Pharmaceutical Inc.
• Treatments: Brexpiprazole

Criteria

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.