A Study of Brexpiprazole in Patients With Major Depressive Disorder

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

July 24, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

July 30, 2018

Estimated Primary Completion Date

July 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean changes from baseline in Montgomery Åsberg Depression Rating Scale (MADRS) total scores at last visit of the double-blind period[ Time Frame: Baseline and Week 14 ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

The proportion of subjects who score 1 or 2 on the Clinical Global Impression-Improvement (CGI-I) scale at Week 14[ Time Frame: Baseline and 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.

Descriptive Information

Brief Title ^ICMJE

A Study of Brexpiprazole in Patients With Major Depressive Disorder

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2/Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Brexpiprazole
Tablets, Oral, once daily, 14 weeks
Drug: Placebo
Tablets, Oral, once daily, 14 weeks

Study Arms

Experimental: Brexpiprazole 1mg
Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI
Experimental: Brexpiprazole 2mg
Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI
Placebo Comparator: Placebo
Tablets, Oral, once daily, 14 weeks

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

720

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2022

Estimated Primary Completion Date

July 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Japan

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Otsuka Pharmaceutical Co., Ltd.

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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