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NCT03427892 · ClinicalTrials.gov registry record · Phase 4
Brexpiprazole for Bipolar Depression
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT03427892 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 21 participants.
The verdict
NCT03427892, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study Summary
The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to assess if brexpiprazole is associated with a reduction in depressive symptom severity using the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary aims will include an assessment of the following in patients with bipolar disorder taking brexpiprazole: manic symptoms, cognition, safety and tolerability of brexpiprazole, and quality of life. Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder, development of active suicidal or homicidal ideation with plan and intent, worsening of mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe life-threatening medical condition, involuntary psychiatric hospitalization or incarceration.
Interventions
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2018-03-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03427892
The ClinicalTrials.gov registry entry for NCT03427892 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Brexpiprazole is the first listed.
NCT03427892 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03427892 about?
NCT03427892 is a clinical study titled "Brexpiprazole for Bipolar Depression". The investigators will conduct an 8-week, non-randomized, open-label study of brexpiprazole in 20 persons with bipolar I or II disorder, depressed mood state. Primary aim will be to assess if brexpiprazole is associated with a reduction in depressive symptom severity using the Montgomery-Asberg Depr...
What is the current status of trial NCT03427892?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2017-03-01. Estimated completion is 2018-03-15.
What interventions are being tested in trial NCT03427892?
The interventions under investigation include: Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT03427892?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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