Study identifier:D1443L00058
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Effectiveness of Quetiapine XR versus Sertraline in acute depression as add-on therapy to previous mood stabilizer treatment: a pilot study
Bipolar Disorder
Phase 3
No
Extended release quetiapine (quetiapine XR), Sertraline, adequate mood stabilizer
All
27
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Mar 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Quetiapine Extended Release Lithium or valproate at stable doses within seric therapeutic levels | Drug: Extended release quetiapine (quetiapine XR) 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. Other Name: SEROQUEL XR® Drug: adequate mood stabilizer 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). |
Active Comparator: Sertraline Lithium or valproate at stable doses within seric therapeutic levels | Drug: Sertraline 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. Other Name: Zoloft Drug: adequate mood stabilizer 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). |