At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 28 enrolled
Drug / intervention
quetiapine SR +1 moredrug
Likely dose
quetiapine SR 600mgfrom 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 Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder
The University of Texas Health Science Center at San Antonio·interventional·Posted Sep 6, 2010·Updated Mar 23, 2017
In Brief
A Phase 4 clinical trial evaluating quetiapine SR and quetiapine sr placebo for Bipolar Disorder. Completed, enrolled 28 participants across 1 site.
Detailed Summary
To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsAstraZeneca
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedSep 2010
Primary CompletionDec 2010
Study CompletionJun 2011
TodayJul 2026
First PostedSep 6, 2010
Enrollment StartApr 1, 2007
Primary CompletionDec 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 15.8 years ago
Interventions
quetiapine SRdrug
quetiapine SR, dose range 200-600mg, each night QHS for 6mos
quetiapine sr placebodrug
quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos