A Study of Brexpiprazole in Patients With Major Depressive Disorder

Recruitment & Eligibility

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
1. Neurocognitive disorders
2. Schizophrenia spectrum and other psychotic disorders
3. Bipolar and related disorders
4. Feeding and eating disorders
5. Obsessive-compulsive disorder
6. Panic disorder
7. Posttraumatic stress disorder

Study & Design

Arm && Interventions

Group	Intervention	Description
Brexpiprazole 1mg	Brexpiprazole	Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI
Brexpiprazole 2mg	Brexpiprazole	Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI
Placebo	Placebo	Tablets, Oral, once daily, 14 weeks

Primary Outcome Measures

Name	Time	Method
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).	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 Outcome Measures

Name	Time	Method
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).	Clinical Global Impression - Improvement (CGI-I) improvement rate: the proportion of participants who score 1 or 2 on the CGI-I scale at Week 6 of the double-blind period (Phase B). The CGI-I Scale was a clinician-rated scale which assessed the total improvement of the participant'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 indicated worse condition.

Recruitment & Eligibility