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

NCT ID: NCT03737474

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-04
• Study Completion Date: 2021-04-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brexpiprazole

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

Group Type: EXPERIMENTAL

Brexpiprazole

Intervention Type: DRUG

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

Interventions

Brexpiprazole

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Rollover subjects

1. Outpatients

2. 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

3. 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

4. Subjects with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode"

• New subjects

1. Outpatients

2. Male and female patients ≥ 65 years of age (at the time of informed consent)

3. 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

4. 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

5. 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

1. 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.

2. Patients with a treatment history showing that all antidepressants (also including those not used for the current major depressive episode) cannot be tolerated

3. Patients with a history of electroconvulsive therapy

4. 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

Exclusion Criteria

• Rollover subjects

1. Female subjects who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at baseline

2. 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.

3. Subjects who experience a change to the manic state in the antidepressant treatment period of the double-blind trial

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanko-kokorono clinic

Shirakawa, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 39424742 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

331-102-00059

Identifier Type: -

Identifier Source: org_study_id