At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 193 enrolled
Drug / intervention
Quetiapine XR +1 moredrug
Likely dose
Quetiapine XR 300 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.
An 8-week, Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended-Release in Children and Adolescent Subjects With Bipolar Depression
In Brief
A Phase 3 clinical trial evaluating Quetiapine XR and Placebo for Bipolar Depression. Completed, enrolled 193 participants across 48 sites in 7 countries.
Detailed Summary
The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesColombia, India, Mexico, Serbia, South Africa, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartJan 2009
Primary CompletionNov 2010
TodayJul 2026
First PostedDec 19, 2008
Enrollment StartJan 1, 2009
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.5 years ago
Interventions
Quetiapine XRdrug
Oral treatment with 150 up to 300 mg/day once daily in the evening
Placebodrug
Oral treatment once daily in the evening