Status:
COMPLETED
Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Lundbeck Canada Inc.
Otsuka Canada Pharmaceutical Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04830215
Start Date
April 1 2021
End Date
May 27 2022
Last Update
February 2 2024
Active Locations (1)
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1
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, Canada, N7L 1C1