Quetiapine XR versus Sertraline in acute bipolar depression as add-on therapy
Study identifier:D1443L00058
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Effectiveness of Quetiapine XR versus Sertraline in acute depression as add-on therapy to previous mood stabilizer treatment: a pilot study
Medical condition
Bipolar Disorder
Phase
Phase 3
Healthy volunteers
No
Study drug
Extended release quetiapine (quetiapine XR), Sertraline, adequate mood stabilizer
Sex
All
Actual Enrollment
27
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 May 2009
Primary Completion Date: 01 Feb 2011
Study Completion Date: 01 Feb 2011
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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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). |
