Major Depressive DisorderPhase 4NCT04830215
Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
A Phase 4 study testing Brexpiprazole in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Brexpiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2021to 27 May 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, N7L 1C1
About this study
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
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.
Read the 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 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Brexpiprazole
- Keywords
- MDD, Depression, Brexpiprazole
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexpiprazoleDrug
Also called OPC-34712
Oral brexpiprazole tablets as adjunctive therapy to ADT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Brexpiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Apr 2021
- Primary completion27 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lundbeck Canada Inc., Otsuka Canada Pharmaceutical Inc.
- Responsible party
- Sponsor
- Investigators
- Eva Kohegyi, MD, Study director, Otsuka Pharmaceutical Development & Commercialization, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830215
- Sponsor's protocol ID
- 331-201-00289
- Status last verified
- May 2023
- First submitted
- 29 Mar 2021
- Last updated
- 2 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40913583Therrien 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.
PubMed 38425284
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04830215
- Acronym / sponsor ID
- 331-201-00289
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Depression, Brexpiprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lundbeck Canada Inc., Otsuka Canada Pharmaceutical Inc.
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Posted 2 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brexpiprazole | Other | Drug: BrexpiprazoleParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrexpiprazoleAlso: OPC-34712Oral brexpiprazole tablets as adjunctive therapy to ADT | Drug | Brexpiprazole |
Primary outcome
Change From Baseline in IDS-SR-10 Engagement
Time frame: Baseline to Week 8
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.
Change From Baseline in IDS-SR Total Score
Time frame: Baseline to Week 8
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40913583Therrien 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.
- Derived from this study: PubMed 38425284Therrien 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Kohegyi, MD study director
Otsuka Pharmaceutical Development & Commercialization, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brexpiprazole in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in IDS-SR-10 Engagement (time frame: Baseline to Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04830215, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.