Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy

Last updated: April 16, 2012
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Depression (Major/severe)

Mood Disorders

Depression

Treatment

N/A

Clinical Study ID

NCT00857584
D1443L00058
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressiveepisode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes)

  • Have been treated with only one mood stabilizer (lithium or valproate) in optimal andstable doses during at least the previous 4 weeks to randomization

  • Hamilton Depression Rating Scale (HDRS-17) total score ≥ 20 and Young Mania RatingScale (YMRS) total score ≤ 14 at the screening and randomization visits - Informedconsent signed

Exclusion

Exclusion Criteria:

  • Patients with any axis I or II Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) diagnoses different from bipolar disorder I orII - 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 otherthan Lithium or valproate, any antidepressant, any antipsychotic or any CP450-3Ainductor/inhibitor within the 7 days period prior to randomization

Study Design

Total Participants: 27
Study Start date:
May 01, 2009
Estimated Completion Date:
February 28, 2011

Connect with a study center

  • Research Site

    Santander, Cantabria
    Spain

    Site Not Available

  • Research Site

    Zamora, Castilla-León
    Spain

    Site Not Available

  • Research Site

    Vigo, Galicia
    Spain

    Site Not Available

  • Research Site

    Vitoria, Pais Vasco
    Spain

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.