A Phase 4 interventional study of Brexpiprazole in Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 4, Interventional, and Treatment
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 122 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with a concurrent DSM-5 diagnosis of the following will be excluded:
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
Oral brexpiprazole tablets as adjunctive therapy to ADT
Also known as: OPC-34712
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.
Time frame: 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.
Time frame: Baseline to Week 8
Participants took part in this study at 15 investigative sites in Canada from 01 April 2021 to 27 May 2022.
| Milestone | Brexpiprazole |
|---|---|
| Started | 122 |
| Efficacy analysis set | 120 |
| Safety analysis set | 120 |
| Completed | 111 |
| Not completed | 11 |
| Withdrew: Adverse event | 6 |
| Withdrew: Failure to meet continuation criteria | 1 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Protocol deviation | 1 |
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.
| score on a scale | Brexpiprazole |
|---|---|
| Change From Baseline in IDS-SR-10 Engagement | -8.11 ± 0.62 |
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.
| score on a scale | Brexpiprazole |
|---|---|
| Change From Baseline in IDS-SR Total Score | -17.38 ± 1.36 |
Collected over From first dose of study drug up to Week 8. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brexpiprazole | 0/120 (0%) | 0/120 (0%) | 45/120 (37.5%) |
| Event | Brexpiprazole |
|---|---|
| FatigueGeneral disorders | 13/120 |
| HeadacheNervous system disorders | 13/120 |
| InsomniaPsychiatric disorders | 12/120 |
| NauseaGastrointestinal disorders | 9/120 |
| TremorNervous system disorders | 8/120 |
| Weight increasedInvestigations | 7/120 |
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.
| Age, Continuous(years) | Brexpiprazole |
|---|---|
| Mean | 43.0 ± 13.1 |
| Sex: Female, Male(Participants) | Brexpiprazole |
|---|---|
| Female | 79 |
| Male | 43 |
| Race/Ethnicity, Customized(Participants) | Brexpiprazole |
|---|---|
| Race — White | 111 |
| Race — Black or African American | 1 |
| Race — Asian | 7 |
| Race — Other | 3 |
| Race/Ethnicity, Customized(Participants) | Brexpiprazole |
|---|---|
| Ethnicity — Hispanic or Latino | 1 |
| Ethnicity — Not Hispanic or Latino | 117 |
| Ethnicity — Unknown | 3 |
| Ethnicity — Other | 1 |
| IDS-SR-10 Engagement(score on a scale) | Brexpiprazole |
|---|---|
| Mean | 16.1 ± 4.7 |
| IDS-SR Total Score(score on a scale) | Brexpiprazole |
|---|---|
| Mean | 41.3 ± 9.8 |
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Otsuka Pharmaceutical Development & Commercialization, Inc.