Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

NCT04830215 | Completed Phase 4 Results

• 1 other identifier: 331-201-00289
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical trial will investigate the effect of brexpiprazole on the concept of life engagement in participants with Major Depressive Disorder (MDD) with a current depressive episode.

Conditions

Major Depressive Disorder

Keywords

MDD; Depression; Brexpiprazole

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in IDS-SR-10 Engagement

  The IDS-SR-10 engagement consist of selected 10 item scores, including the following 10 items (clinician-selected): item 8 - Response of your mood to good or desired events, item 15 - Concentration/decision making, item 16 - View of myself, item 17 - View of my future, item 19 - General interest, item 20 - Energy level, item 21 - Capacity for pleasure or enjoyment (excluding sex), item 22 - Interest in sex (interest rated, not activity), item 23 - Feeling slowed down, and item 29- Interpersonal sensitivity. All the 10 items are rated on a 0 (best) to 3 (worst) scale. IDS-SR-10 engagement total score ranges from 0 (best) to 30 (worst). A negative change from baseline indicated improvement. Least square (LS) mean was calculated using a mixed model repeated measure (MMRM) analysis.

  Baseline to Week 8

• Change From Baseline in IDS-SR Total Score

  The IDS-SR is a 30-item self-report measure that was used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorder (MDD). Each item on the IDS-SR scale was rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. IDS-SR total score is the sum of ratings of 28 item scores with the total score ranging from 0 (best) to 84 (worst). Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. A negative change from baseline indicated improvement. LS mean was calculated using a MMRM analysis.

  Baseline to Week 8

Study Arms (1)

Brexpiprazole

OTHER

Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, orally (PO), QD, and continued on the stable dose of ADT up to 8 weeks.

Drug: Brexpiprazole

Interventions

Brexpiprazole DRUG

Oral brexpiprazole tablets as adjunctive therapy to ADT

Also known as: OPC-34712

Brexpiprazole

Eligibility Criteria

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

You may qualify if:

• Male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent.
• Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs in their current MDE, including current ADT.
• Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate.

You may not qualify if:

• Participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial.
• Participants with a concurrent DSM-5 diagnosis of the following will be excluded:
• Schizophrenia or schizoaffective disorder
• Bipolar I or bipolar II disorder
• Post-traumatic stress disorder
• Dementia
• Eating disorder
• Borderline personality disorder
• Antisocial personality disorder
• Participants with a suicidality score of 3 based on Inventory of Depressive Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the opinion of the investigator, presents a serious risk of suicide.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Lundbeck Canada Inc.: collaborator
• Otsuka Canada Pharmaceutical Inc.: collaborator

Study Sites (1)

Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, N7L 1C1, Canada

Location

Related Publications (2)

• Therrien F, Chokka P, Habert J, Ismail Z, McIntyre RS, Dine J, Brown TM, Zhang Z, MacKenzie EM, Ward CL. Patient-reported efficacy of adjunctive brexpiprazole in major depressive disorder in a phase 4, open-label, interventional study. Curr Med Res Opin. 2025 Aug;41(8):1511-1522. doi: 10.1080/03007995.2025.2558140. Epub 2025 Sep 16.

  PMID: 40913583 DERIVED

• Therrien F, Ward C, Chokka P, Habert J, Ismail Z, McIntyre RS, MacKenzie EM. Adjunctive Brexpiprazole for Patient Life Engagement in Major Depressive Disorder: A Canadian, Phase 4, Open-Label, Interventional Study: Brexpiprazole d'appoint pour l'engagement dans la vie des patients souffrant de trouble depressif majeur: une etude interventionnelle canadienne ouverte de phase 4. Can J Psychiatry. 2024 Jul;69(7):513-523. doi: 10.1177/07067437241233965. Epub 2024 Mar 1.

  PMID: 38425284 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Global Clinical Development
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

clinicaltransparency@otsuka-us.com

1-609-524-6788

Study Officials

• Eva Kohegyi, MD

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 5, 2021
• Study Start: April 1, 2021
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: February 2, 2024
• Results First Posted: February 2, 2024

Record last verified: 2023-05

Locations

CA (1)