At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 139 enrolled
Drug / intervention
Quetiapine Immediate Release +1 moredrug
Likely dose
Quetiapine Immediate Release 25 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.
A Phase IV, Multi-center, Double-blind, Double-dummy, Randomized, Parallel-group Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (Seroquel IR) With Quetiapine Fumarate Extended Release (Seroquel XR) During Initial Dose Escalation in Patients With Bipolar Depression
In Brief
A Phase 4 clinical trial evaluating Quetiapine Immediate Release and Quetiapine Extended Release for Bipolar Depression. Completed, enrolled 139 participants.
Detailed Summary
The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJun 2009
Primary CompletionAug 2009
TodayJul 2026
First PostedJun 23, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.0 years ago
Interventions
Quetiapine Immediate Releasedrug
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Quetiapine Extended Releasedrug
Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day