Phase 3
N=740
A Study of Brexpiprazole in Patients With Major Depressive Disorder
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03697603 ↗Enrolled (actual)
740
Serious AEs
1.1%
Results posted
Aug 2024
Primary outcome: Primary: Mean Changes From Baseline (Week 8 of the Antidepressant Treatment Period [Phase A]) in the MADRS Total Scores at Week 6 of the Double-blind Period (Phase B). — -8.5; -8.2; -6.7 Units on a scale — p=0.0312
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole (Drug); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Changes From Baseline (Week 8 of the Antidepressant Treatment Period [Phase A]) in the MADRS Total Scores at Week 6 of the Double-blind Period (Phase B). |
-8.5; -8.2; -6.7 | 0.0312 sig |
| SECONDARY CGI-I Improvement Rate at Week 6 of the Double-blind Period (Phase B) |
35.1; 35.1; 29.6 | 0.1964 |
Summary
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.
Eligibility Criteria
Inclusion Criteria
- Outpatients, or inpatients at the time of informed consent whose treatment status can be successfully shifted to outpatient status before enrollment in the antidepressant treatment period
- Male and female patients ≥ 20 to < 65 years of age (at the time of informed consent)
- Patients who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial
- Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode," and whose current episode has persisted for at least 8 weeks
Exclusion Criteria
- Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening
- Sexually active male subjects or sexually active female subjects of childbearing potential, who will not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after the final
IMP administration. For birth control, 2 of the following methods must be used:
vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide.
- Patients with a treatment history showing that all antidepressants (including those not used for the current major depressive episode) cannot be tolerated
- Patients with a history of electroconvulsive therapy
- Patients with a diagnosis of any of the following diseases according to DSM-5
- Neurocognitive disorders
- Schizophrenia spectrum and other psychotic disorders
- Bipolar and related disorders
- Feeding and eating disorders
- Obsessive-compulsive disorder
- Panic disorder
- Posttraumatic stress disorder
Data sourced from ClinicalTrials.gov (NCT03697603). 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.