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NCT00397020 · ClinicalTrials.gov registry record · Phase 4
Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes
A Phase 4 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT00397020 is a Phase 4 study that has completed, run by University of California, San Diego. The registered enrollment target is 30 participants.
The verdict
NCT00397020, a Phase 4 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses will be tested: Hypothesis 1: treatment ( 3 weeks) of divalproex extended-release is similar to quetiapine in the symptomatic control of mania or mixed mania Hypothesis 2: divalproex extended-release orally loaded may produce significant improvements in symptoms of mania sooner than quetiapine Hypothesis 3: divalproex extended-release may produce significantly less sedation
Interventions
- DRUG quetiapine
- DRUG divalproex ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00397020
The ClinicalTrials.gov registry entry for NCT00397020 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which quetiapine is the first listed.
NCT00397020 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00397020 about?
NCT00397020 is a clinical study titled "Naturalistic Study, Comparison of Divalproex Extended Release (ER) and Quetiapine for Adults With Acute Mania or Mixed Episodes". The primary objective of this study is to compare the efficacy and tolerability of quetiapine versus divalproex extended-release administered in a rapid oral loading fashion in the treatment of acute episodes of mania or mixed mania in bipolar disorder. Three hypotheses will be tested: Hypothesis 1...
What is the current status of trial NCT00397020?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2006-12. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00397020?
The interventions under investigation include: quetiapine (DRUG), divalproex ER (DRUG).
Who is sponsoring clinical trial NCT00397020?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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