A Long-Term Study of Brexpiprazole in Patients With Major Depressive Disorder

NCT03737474 | Completed Phase 3 Results

• 1 other identifier: 331-102-00059
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

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

  From baseline to week 52

Secondary Outcomes (5)

• Mean Changes From Baseline in Montgomery Åsberg Depression Rating Scale(MADRS) 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 Hamiliton Depression Rating Scale(HAM-D) Item Total Scores 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)

Study Arms (1)

Brexpiprazole

EXPERIMENTAL

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

Drug: Brexpiprazole

Interventions

Brexpiprazole DRUG

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

Brexpiprazole

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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
• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Nanko-kokorono clinic

Shirakawa, Japan

Location

Related Publications (1)

• Kato M, Shiosakai M, Kuwahara K, Iba K, Shimada Y, Saito M, Sekine D, Aoki K, Shiomi Y, Higuchi T. A Multicenter, Open-Label Study to Evaluate the Long-term Safety and Efficacy of Adjunctive Brexpiprazole 2 mg Daily in Japanese Patients with Major Depressive Disorder. CNS Drugs. 2024 Dec;38(12):1003-1016. doi: 10.1007/s40263-024-01124-w. Epub 2024 Oct 18.

  PMID: 39424742 DERIVED

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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: November 9, 2018
• Study Start: October 4, 2018
• Primary Completion: March 17, 2021
• Study Completion: April 13, 2021
• Last Updated: April 29, 2024
• Results First Posted: April 29, 2024

Record last verified: 2023-11

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)