A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial to Assess the Efficacy and Safety of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder
Overview
- Phase
- Phase 2
- Intervention
- Brexpiprazole
- Conditions
- Major Depressive Disorder
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Enrollment
- 740
- Locations
- 1
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
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
Arms & Interventions
Brexpiprazole 1mg
Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI
Intervention: Brexpiprazole
Brexpiprazole 2mg
Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI
Intervention: Brexpiprazole
Placebo
Tablets, Oral, once daily, 14 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
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).
Time Frame: Baseline (the end of Phase A), at completion of administration (Week 6).
The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consisted of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item was scored from 0 to 6, with higher scores indicating worse condition. Summed subscales were combined to compute a total score. Total score ranges from 0 to 60, with higher scores indicating worse condition.The mean changes were compared between antidepressant treatments and brexpiprazole as adjunctive therapy.
Secondary Outcomes
- CGI-I Improvement Rate at Week 6 of the Double-blind Period (Phase B)(Baseline (the end of Phase A), at completion of administration (Week 6).)