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Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Brexpiprazole

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring MDD, Depression, Brexpiprazole

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female patients (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 MDE as defined by 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.
Patients with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate.

Exclusion Criteria:

Patients currently or previously treated with brexpiprazole including patients who received brexpiprazole in any prior clinical trial.
Patients 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
Patients with a suicidality score of 3 based on IDS-SR suicidality item 18 or patients who, in the opinion of the investigator, presents a serious risk of suicide.

Sites / Locations

Chatham-Kent Clinical Trials Research Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Brexpiprazole

Arm Description

Brexpiprazole as a flexible dose; 0.5 to 2 mg/day and patient will continue on the stable dose of ADT that they were taking at screening.

Outcomes

Primary Outcome Measures

Inventory of Depressive Symptomatology Self-Report (IDS-SR) 10-life engagement

Change from baseline to Week 8 in IDS-SR-10- life engagement

Inventory of Depressive Symptomatology Self-Report (IDS-SR) Total score

Change from baseline to Week 8 in IDS-SR Total score

Secondary Outcome Measures

Full Information

NCT ID

NCT04830215

First Posted

March 29, 2021

Last Updated

June 28, 2022

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Lundbeck Canada Inc., Otsuka Canada Pharmaceutical Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04830215

Brief Title

Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

Official Title

A Phase 4, Multicenter, Open-label, Interventional Trial to Assess the Effects on Engagement of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy for the Treatment of Adults With Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

May 27, 2022 (Actual)

Study Completion Date

May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Lundbeck Canada Inc., Otsuka Canada Pharmaceutical Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The clinical trial will investigate the effect of brexpiprazole on the concept of life engagement in patients with MDD with a current depressive episode.

Detailed Description

This is a phase 4, multicenter, open-label, flexible dose trial designed to assess the effects of brexpiprazole (flexible dose; 0.5 to 2 mg QD) as adjunctive therapy to ADT on life engagement in patients with MDD. This trial is being conducted in line with the Canadian Product Monograph.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

MDD, Depression, Brexpiprazole

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brexpiprazole

Arm Type

Other

Arm Description

Brexpiprazole as a flexible dose; 0.5 to 2 mg/day and patient will continue on the stable dose of ADT that they were taking at screening.

Intervention Type

Drug

Intervention Name(s)

Brexpiprazole

Other Intervention Name(s)

OPC-34712

Intervention Description

Brexpiprazole (flexible dose; 0.5 to 2 mg once daily [QD]) as adjunctive therapy to antidepressant therapy (ADT)

Primary Outcome Measure Information:

Title

Inventory of Depressive Symptomatology Self-Report (IDS-SR) 10-life engagement

Description

Change from baseline to Week 8 in IDS-SR-10- life engagement

Time Frame

Change from baseline to Week 8

Title

Inventory of Depressive Symptomatology Self-Report (IDS-SR) Total score

Description

Change from baseline to Week 8 in IDS-SR Total score

Time Frame

Change from baseline to Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female patients (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 MDE as defined by 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. Patients with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate. Exclusion Criteria: Patients currently or previously treated with brexpiprazole including patients who received brexpiprazole in any prior clinical trial. Patients 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 Patients with a suicidality score of 3 based on IDS-SR suicidality item 18 or patients who, in the opinion of the investigator, presents a serious risk of suicide.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eva Kohegyi, MD

Organizational Affiliation

Otsuka Pharmaceutical Development & Commercialization, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Chatham-Kent Clinical Trials Research Centre

City

Chatham

State/Province

Ontario

ZIP/Postal Code

N7L 1C1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

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