Phase 4
Completed N=122
Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
Source: ClinicalTrials.gov NCT04830215 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Change From Baseline in IDS-SR-10 Engagement — -8.11 score on a scale — p=<0.0001
◆ Published Evidence
Emerging
6citations · ~3 / year
Adjunctive Brexpiprazole for Patient Life Engagement in Major Depressive Disorder: A Canadian, Phase 4, Open-Label, Interventional Study: Brexpiprazole d'appoint pour l'engagement dans la vie des patients souffrant de trouble dépressif majeur: une étude interventionnelle canadienne ouverte de phase 4.
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.
Linked Publications (2)
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Adjunctive Brexpiprazole for Patient Life Engagement in Major Depressive Disorder: A Canadian, Phase 4, Open-Label, Interventional Study: Brexpiprazole d'appoint pour l'engagement dans la vie des patients souffrant de trouble dépressif majeur: une étude interventionnelle canadienne ouverte de phase 4.
-
Patient-reported efficacy of adjunctive brexpiprazole in major depressive disorder in a phase 4, open-label, interventional study.
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 |
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) and the linked publication. 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. Informational only — not medical advice.