A Multi-center, Open-label Trial to Assess the Long-term Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder

Otsuka Pharmaceutical Co., Ltd.1 site in 1 country248 target enrollmentOctober 4, 2018

ConditionsMajor Depressive Disorder

InterventionsBrexpiprazole

DrugsBrexpiprazole

Overview

Phase: Phase 3
Intervention: Brexpiprazole
Conditions: Major Depressive Disorder
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Enrollment: 248
Locations: 1
Primary Endpoint: The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is a 52-week study to assess the safety of long-term use of brexpiprazole as adjunctive therapy in combination with an antidepressant.

Registry

clinicaltrials.gov

Start Date

October 4, 2018

End Date

April 13, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Rollover subjects
•Outpatients
•Subjects who have completed the double-blind period of the double-blind trial and can commence the treatment period of this trial within 28 days from the completionof the double-blind period of the double-blind trial
•Subjects 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
•Subjects with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode"
•New subjects
•Outpatients
•Male and female patients ≥ 65 years of age (at the time of informed consent)
•Subjects 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" whose current episode has persisted for at least 8 weeks

Exclusion Criteria

•Rollover subjects
•Female subjects who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at baseline
•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.
•Subjects who experience a change to the manic state in the antidepressant treatment period of the double-blind trial
•Subjects who are discovered to not meet the inclusion criteria or to fall under any of the exclusion criteria in the doubleblind trial
•Subjects who showed marked noncompliance with the IMP treatment in the double-blind trial (subjects whose IMP compliance rates are \< 65% between prescribed visits)
•New subjects
•Sexually active male subjects who will not agree to practice 2different 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 (also including those not used for the current major depressive episode) cannot be tolerated
•Patients with a history of electroconvulsive therapy

Arms & Interventions

Brexpiprazole

2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily

Intervention: Brexpiprazole

Outcomes

Primary Outcomes

The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)

Time Frame: From baseline to week 52

A treatment-emergent adverse event (TEAE) was defined as an AE that started after start of investigational medicinal product (IMP) treatment.

Secondary Outcomes

Mean Changes From Baseline in Montgomery Åsberg Depression Rating Scale(MADRS) Total Scores at Week 52(LOCF)(Baseline and Week 52(LOCF))
Mean Changes From Baseline in Hamiliton Depression Rating Scale(HAM-D) Item Total Scores at Week 52(LOCF)(Baseline and Week 52 (LOCF))
The Proportion of Subjects Who Score 1 or 2 on the Clinical Global Impression-Improvement(CGI-I) Scale at Week 52(LOCF)(Baseline and Week 52 (LOCF))
Mean Changes From Baseline in Clinical Global Impression-Severity of Illness(CGI-S) at Week 52(LOCF)(Baseline and Week 52 (LOCF))
Mean Changes From Baseline in Sheehan Disability Scale (SDS) Scores at Week 52(LOCF)(Baseline and Week 52 (LOCF))