Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

Otsuka

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04830215

331-201-00289

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

Brexpiprazole

Other group

Description:

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.

Treatment:

Drug: Brexpiprazole