Quetiapine XR vs Sertraline in Acute Bipolar Depression as add-on Therapy
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Bipolar Depression
Intervention: Quetiapine XR (Drug); sertraline (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: AstraZeneca Overall contact:
AstraZeneca Spain Clinical Study Information, Phone: +34 660 100 659, Email: Esther.Prieto@astrazeneca.com
Summary
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.
Clinical Details
Official title: Effectiveness of Quetiapine XR vs Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: Change from baseline in the Montgomery Asberg Depression Rating Scale (MDRAS) global score at week 2 (V3, LOCF) endpoint in each treatment group.
Secondary outcome: 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.Response rate, defined as % of patients with a reduction of MADRS global score =50% from baseline, in each assessment (LOCF) for each treatment group. Change in the CGI-BP-M depression subscale and general scale score from baseline in each assessment (LOCF) for each treatment group.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
AstraZeneca Spain Clinical Study Information, Phone: +34 660 100 659, Email: Esther.Prieto@astrazeneca.com
Research Site, Santander, Cantabria, Spain; Recruiting
Research Site, Zamora, Castilla-León, Spain; Not yet recruiting
Research Site, Vigo, Galicia, Spain; Not yet recruiting
Research Site, Vitoria, Pais Vasco, Spain; Recruiting
Additional Information
Starting date: May 2009
Ending date: June 2010
Last updated: September 29, 2009
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