Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lundbeck Canada Inc. | INDUSTRY |
| Otsuka Canada Pharmaceutical Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
This is a phase 4, multicenter, open-label, flexible dose trial designed to assess the effects of brexpiprazole (flexible dose; 0.5 to 2 milligrams [mg], once daily [QD]) as adjunctive therapy to antidepressant therapy (ADT) on life engagement in participants with MDD. This trial is being conducted in line with the Canadian Product Monograph.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | Oral brexpiprazole tablets as adjunctive therapy to ADT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eva Kohegyi, MD | Otsuka Pharmaceutical Development & Commercialization, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chatham-Kent Clinical Trials Research Centre | Chatham | Ontario | N7L 1C1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40913583 | Derived | 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. | |
| 38425284 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 157 participants were screened of which 122 participants were enrolled and 120 participants were treated in the study.
Participants took part in this study at 15 investigative sites in Canada from 01 April 2021 to 27 May 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Brexpiprazole | Participants received brexpiprazole as a flexible dose; 0.5 milligrams (mg) to 2 mg, orally (PO), once daily (QD), and continued on the stable dose of antidepressant therapy (ADT) up to 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Enrolled Analysis Set included all participants who had signed the informed consent form (ICF) for the trial and had enrolled into the open-label treatment phase.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brexpiprazole | Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, PO, QD, and continued on the stable dose of ADT up to 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Efficacy Analysis Set included all participants who had a baseline value and at least one post-baseline efficacy evaluation for IDS-SR total score and IDS-SR-10-engagement during the open label treatment phase. Overall number analyzed is the number of participants with data available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 8 |
From first dose of study drug up to Week 8
The Safety Analysis Set included all participants who received at least one dose of open-label brexpiprazole.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brexpiprazole | Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, PO, QD, and continued on the stable dose of ADT up to 8 weeks. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Development | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1-609-524-6788 | clinicaltransparency@otsuka-us.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2021 | May 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2022 | May 24, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| Protocol Deviation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| IDS-SR-10 Engagement | Efficacy Analysis Set included all participants who had a baseline value and at least one post-baseline efficacy evaluation for IDS-SR total score and IDS-SR-10 engagement during the open label treatment phase. IDS-SR-10-engagement consist of selected 10 item scores, including the following 10 items (clinician-selected): items 8, 15, 16, 17, 19, 20, 21, 22, 23, and 29. All 10 items are rated on a 0 (best) to 3 (worst) scale. The total score ranges from 0 (best) to 30 (worst). | Mean | Standard Deviation | score on a scale |
|
| IDS-SR Total Score | Efficacy Analysis Set. IDS-SR is 30-item self-report measure used to assess core diagnostic depressive symptoms & atypical & melancholic symptom features of major depressive disorder(MDD).Each item rated=0(best)-3(worst).It is sum of ratings of 28 items. Total score=0(best)-84(worst).Item 9 has 2 subitems 9A (score=1,2,&3)& 9B (score=0 or 1).Scores for 9A & 9B are not included in calculation of total score.Item 11/12 should be completed but not both, item 13/14 should be completed but not both. | Mean | Standard Deviation | score on a scale |
|
| ID | Title | Description |
|---|
| OG000 | Brexpiprazole | Participants received brexpiprazole as a flexible dose; 0.5 mg to 2 mg, PO, QD, and continued on the stable dose of ADT up to 8 weeks. |
|
|
|
| Primary | 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. | The Efficacy Analysis included all participants who had a baseline value and at least one post-baseline efficacy evaluation for IDS-SR total score and IDS-SR-10-engagement during the open label treatment phase. Overall number analyzed is the number of participants with data available for analysis. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 8 |
|
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 45 |
| 120 |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
Not provided
| D001519 |
| Behavior |