At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 78 enrolled
Drug / intervention
Lithium Carbonate +3 moredrug
Likely dose
Not stated in 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.
Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode
In Brief
A Phase 4 clinical trial evaluating Lithium Carbonate, Sertraline, and 2 other interventions for Bipolar Disorder. Completed, enrolled 78 participants.
Detailed Summary
To evaluate the effectiveness of an algorithm for Bipolar Disorder depressive episodes (BDD) using medications available in the Brazilian Public Healthcare System (SUS). Quality of life assessment of these patients was also employed. A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of episodes of bipolar disorder depression episodes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
Countries--
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
Primary CompletionNov 2014
Study CompletionSep 2015
First PostedSep 2016
TodayJul 2026
First PostedSep 28, 2016
Enrollment StartMay 1, 2010
Primary CompletionNov 1, 2014
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.8 years ago
Interventions
Lithium Carbonatedrug
Sertralinedrug
Nortriptylinedrug
Risperidonedrug