Phase 4
N=122
Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04830215 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change From Baseline in IDS-SR-10 Engagement — -8.11 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Brexpiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in IDS-SR-10 Engagement |
-8.11 | <0.0001 sig |
| PRIMARY Change From Baseline in IDS-SR Total Score |
-17.38 | <0.0001 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04830215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.