CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 421 enrolled
Drug / intervention
Quetiapine fumarate XR +1 moredrug
Likely dose
Quetiapine fumarate 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/NCT00883493
NCT00883493Phase 3Completed
CompareCT.gov

A Randomised, Multi-Centre Study to Compare the Efficacy and Safety of Extended Release Quetiapine Fumarate (Seroquel XR TM) Tablets as Mono-Therapy or in Combination With Lithium in the Treatment of Patients With Acute Bipolar Depression

AstraZeneca·interventional·Posted Apr 17, 2009·Updated Jul 11, 2012

In Brief

A Phase 3 clinical trial evaluating Quetiapine fumarate XR and Lithium carbonate for Acute Bipolar Depression. Completed, enrolled 421 participants across 24 sites in 9 countries.

Detailed Summary

The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Bipolar Depression
CountriesArgentina, Brazil, Chile, Colombia, Guatemala, Mexico, Peru, Turkey (Türkiye), Venezuela
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2009
Enrollment StartApr 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.2 years ago

Interventions

Quetiapine fumarate XRdrug

Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.

Lithium carbonatedrug

Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day