Official Title: “Effectiveness of Quetiapine XR vs Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study”

Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of Quetiapine XR vs. 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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Quetiapine XR
  • Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length
• Drug: sertraline
  • Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Lithium or valproate at stable doses within seric therapeutic levels
• Active Comparator: 2
  • Lithium or valproate at stable doses within seric therapeutic levels

Primary Measures

• Change from baseline in the Montgomery Asberg Depression Rating Scale (MDRAS) global score at week 2 (V3, LOCF) endpoint in each treatment group.
  • Time Frame: Week 2
    Safety Issue?: No

Secondary Measures

• Change in the Montgomery Asberg Depression Rating Scale (MADRS) and in the Young Mania rating Scale (YMRS) global score from baseline to each assessment (LOCF) endpoint in each treatment group.
  • Time Frame: Every patient visit (week 1, week 2, week 4 and week 8)
    Safety Issue?: No
• Response rate, defined as % of patients with a reduction of MADRS global score =50% from baseline, in each assessment (LOCF) for each treatment group.
  • Time Frame: Every patient visit (week 1, week 2, week 4 and week 8)
    Safety Issue?: No
• Change in the CGI-BP-M depression subscale and general scale score from baseline in each assessment (LOCF) for each treatment group.
  • Time Frame: Every patient visit (week 1, week 2, week 4 and week 8)
    Safety Issue?: No

Inclusion Criteria:

• Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressive episode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes)
• Have been treated with only one mood stabilizer (lithium or valproate) in optimal and stable doses during at least the previous 4 weeks to randomization.
• HDRS-17 global score=20 or above and YMRS =14 or above at the screening and randomisation visits.
• Informed consent signed

Exclusion Criteria:

• Patients with any axis I or II DSM-IV-TR diagnoses different from bipolar disorder I or II
• Length of current depressive episode less than 2 weeks or more than 12 months.
• Having been treated with more than one mood stabilizer or any mood stabilizer other than Lithium or valproate, any antidepressant, any antipsychotic or any CP450-3A inductor/inhibitor within the 7 days period prior to randomization

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Overall Contact: AstraZeneca Spain Clinical Study Information +34 660 100 659 Esther.Prieto@astrazeneca.com

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00857584

Study ID Number: D1443L00058

ClinicalTrials.gov Identifier: NCT00857584

Health Authority: Spain: Comité Ético de Investigación Clínica