A Study of Brexpiprazole in Patients With Major Depressive Disorder

NCT03697603 | Completed Phase 2 Results

• 1 other identifier: 331-102-00058
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  Baseline (the end of Phase A), at completion of administration (Week 6).

Secondary Outcomes (1)

• 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).

Study Arms (3)

Brexpiprazole 1mg

EXPERIMENTAL

Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI

Drug: Brexpiprazole

Brexpiprazole 2mg

EXPERIMENTAL

Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI

Drug: Brexpiprazole

Placebo

PLACEBO COMPARATOR

Tablets, Oral, once daily, 14 weeks

Drug: Placebo

Interventions

Brexpiprazole DRUG

Tablets, Oral, once daily, 14 weeks

Also known as: REXULTI

Brexpiprazole 1mg; Brexpiprazole 2mg

Placebo DRUG

Tablets, Oral, once daily, 14 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Nanko-kokorono clinic

Fukushima, Japan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: October 5, 2018
• Study Start: July 30, 2018
• Primary Completion: June 6, 2022
• Study Completion: July 4, 2022
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)