A Study of Brexpiprazole in Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Brexpiprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brexpiprazole 1mg<br>Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI | Drug: Brexpiprazole<br>* Tablets, Oral, once daily, 14 weeks<br>* Other names: REXULTI;|
| Experimental: Brexpiprazole 2mg<br>Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI | Drug: Brexpiprazole<br>* Tablets, Oral, once daily, 14 weeks<br>* Other names: REXULTI;|
| Placebo Comparator: Placebo<br>Tablets, Oral, once daily, 14 weeks | Drug: Placebo<br>* Tablets, Oral, once daily, 14 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean changes from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total scores at last visit of the double-blind period | The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists 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 is scored from 0 to 6, with higher scores indicating worse condition. | Baseline and Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement (CGI-I) scale at Week 14 | The CGI-I Scale is a clinician-rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7:0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. | Baseline and Week 14 |