CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 224 enrolled
Drug / intervention
quetiapine SR +2 moredrug
Likely dose
quetiapine SR 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00579280
NCT00579280Phase 4Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Study of Quetiapine SR and Divalproex Sodium ER on Anxiety in Bipolar Disorder With at Least Moderately Severe Current Anxiety and Lifetime Panic or Generalized Anxiety Disorder.

University of South Florida·interventional·Posted Dec 24, 2007·Updated Jun 11, 2020

In Brief

A Phase 4 clinical trial evaluating quetiapine SR, divalproex sodium ER, and 1 other intervention for Bipolar Disorder and 2 related conditions. Completed, enrolled 224 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Panic Disorder, Generalized Anxiety Disorder
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 24, 2007
Enrollment StartJul 1, 2007
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.5 years ago

Interventions

quetiapine SRdrug

flexible dosing, 50 mg up to a maximum of 300 mg per day for 8 weeks

divalproex sodium ERdrug

Flexible dosing, 500 mg up to a maximum of 3000 mg per day for 8 weeks

placebodrug

placebo