Clinical trial NCT04830215: Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: MDD
Depression
Brexpiprazole
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Lundbeck Canada Inc.
name: Otsuka Canada Pharmaceutical Inc.
First posted: 2021-04-05
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in IDS-SR-10 Engagement
timeFrame: Baseline to Week 8
measure: Change From Baseline in IDS-SR Total Score
timeFrame: Baseline to Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Chatham
country: Canada
facility: Chatham-Kent Clinical Trials Research Centre
state: Ontario
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Eva Kohegyi, MD
role: STUDY_DIRECTOR
References: