CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
Quetiapine XR +1 moredrug
Likely dose
Quetiapine XR 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/NCT00671853
NCT00671853Phase 3Completed
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Quetiapine XR in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression With or Without Substance Use Disorder

University Hospitals Cleveland Medical Center·interventional·Posted May 5, 2008·Updated Dec 29, 2016

In Brief

A Phase 3 clinical trial evaluating Quetiapine XR and Placebo for quetiapine XR for Bipolar Disorder and 3 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed Summary

The primary objective is to test the hypothesis that Quetiapine XR (Extended Release) monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. The secondary aim is to generate an estimate of effect size to power a definitive large-scale, multi-site collaborative R01 and to configure the use of the primary and secondary outcome measures in the definitive large-scale study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Anxiety, Anxiety Disorders, Substance Use Disorders
CountriesUnited States
CollaboratorsNational Alliance for Research on Schizophrenia and Depression, AstraZeneca

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 5, 2008
Enrollment StartApr 1, 2008
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 18.2 years ago

Interventions

Quetiapine XRdrug

Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day

Placebo for quetiapine XRdrug

Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day