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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03538691
The ClinicalTrials.gov registry entry for NCT03538691 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,149 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 373-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (208% higher). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.