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NCT03538691 · ClinicalTrials.gov registry record · Phase 3
A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,149
- Enrollment target
- 1
- Study location
NCT03538691: Completed Phase 3 study of Major Depressive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03538691 is a Phase 3 study of Major Depressive Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,149 participants, above the 373-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (208% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03538691, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,149 participants
- Enrollment target
- 1
- Study location
Study Summary
Major depressive disorder (MDD) is a serious medical illness associated with significant suicidal risk and marked disability. Despite the availability of numerous treatments, achievement of consistent and favorable long-term outcomes remains challenging. This study will assess the safety, efficacy and tolerability of brexpiprazole as adjunctive therapy to protocol-specific open-label antidepressant therapy.
Primary Outcome
Relapse criteria included:At same visit, increase in Montgomery Asberg Depression Rating Scale\[MADRS\] total score(10 items, 0=no symptoms to 6=severe symptoms,total score=0 to 60)of 50% from randomization and Clinical Global Impression-Severity of Illness \[CGI-\](8-point scale of 0=not assessed to 7=most extremely ill)score ≥4,hospitalization for depression, discontinuation for lack of efficacy/worsening of depression, active suicidality(score of ≥4 on MADRS item10 of suicidality)or yes answe
Conditions Studied
Interventions
- DRUG Brexpiprazole
- DRUG Antidepressant therapy
Study Locations (1)
California
- For additional information regarding sites, contact 844-687-8522 - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,149 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2022-07-29 |
| Phase | Phase 3 |
What the finished NCT03538691 record still lists
NCT03538691 is an interventional study that assigns participants to a tested intervention. Its 1,149 participants enrollment target places it among the larger protocols in the corpus, above the 373-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (208% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Brexpiprazole is the first listed.
NCT03538691 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03538691 about?
NCT03538691 is a clinical study titled "A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder". Major depressive disorder (MDD) is a serious medical illness associated with significant suicidal risk and marked disability. Despite the availability of numerous treatments, achievement of consistent and favorable long-term outcomes remains challenging. This study will assess the safety, efficacy ...
What is the current status of trial NCT03538691?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,149 participants. The study started on 2018-07-13. Estimated completion is 2022-07-29.
What conditions does trial NCT03538691 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT03538691?
The interventions under investigation include: Brexpiprazole (DRUG), Antidepressant therapy (DRUG).
Who is sponsoring clinical trial NCT03538691?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03538691 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03538691's enrollment target sits among peer trials
1,149 5th of 282 higher than 278 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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