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NCT00579280 · ClinicalTrials.gov registry record · Phase 4
Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD
A Phase 4 study, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 224
- Enrollment target
NCT00579280: Completed Phase 4 study, sponsored by University of South Florida.
NCT00579280 is a Phase 4 study that has completed, run by University of South Florida. The registered enrollment target is 224 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00579280, a Phase 4 study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 224 participants
- Enrollment target
Study Summary
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
Primary Outcome
The CGI-21 Anxiety is a 21-point clinician-rated global improvement for anxiety symptoms. Response range: -10 to +10. The higher the score the more improvement. At Baseline all patients have a score of "0" (zero), against which any subsequent improvements or deterioration is assessed. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA). The focus was on the "treatment-by-time" effect showing whether th
Interventions
- DRUG placebo
- DRUG divalproex sodium ER
- DRUG quetiapine SR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
What the finished NCT00579280 record still lists
NCT00579280 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00579280 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00579280 about?
NCT00579280 is a clinical study titled "Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD". The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and c...
What is the current status of trial NCT00579280?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 224 participants. The study started on 2007-07. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00579280?
The interventions under investigation include: placebo (DRUG), divalproex sodium ER (DRUG), quetiapine SR (DRUG).
Who is sponsoring clinical trial NCT00579280?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00579280's enrollment target sits among peer trials
224 379th of 2000 higher than 1,618 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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