CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 27 enrolled
Drug / intervention
Extended release quetiapine (quetiapine XR) +2 moredrug
Likely dose
Quetiapine XR 300–600 mg orally daily; sertraline 50–200 mg orally dailyAI-extracted
Key inclusion· 4
  • ✓Diagnosis of bipolar disorder type I or II with current depressive episode
  • ✓Currently treated with exactly one mood stabilizer (lithium or valproate) at optimal stable doses for ≥4 weeks
  • ✓HDRS-17 total score ≥20 and YMRS total score ≤14 at screening and randomization
  • ✓Ambulatory (outpatient) status
Key exclusion· 4
  • ✕Any psychiatric diagnosis other than bipolar disorder I or II
  • ✕Current depressive episode duration <2 weeks or >12 months
  • ✕Prior treatment with >1 mood stabilizer, or with any mood stabilizer other than lithium or valproate
  • ✕Any antidepressant, antipsychotic, or CYP450-3A inductor/inhibitor within 7 days prior to randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00857584
NCT00857584Phase 3Completed
CompareCT.gov

Effectiveness of Quetiapine XR Versus Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study

AstraZeneca·interventional·Posted Mar 6, 2009·Updated Apr 18, 2012

In Brief

A Phase 3 clinical trial evaluating Extended release quetiapine (quetiapine XR), Sertraline, and 1 other intervention for Bipolar Disorder and Bipolar Depression. Completed, enrolled 27 participants across 4 sites.

Detailed Summary

Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR) versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in the treatment of the adult bipolar depression. This multicentric study will be featured in two sites in Spain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Bipolar Depression
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2009
Enrollment StartMay 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.3 years ago

Interventions

Extended release quetiapine (quetiapine XR)drug

Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study.

Sertralinedrug

Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length. Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study.

adequate mood stabilizerdrug

An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively).