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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder; Bipolar Depression

Intervention: Extended release quetiapine (quetiapine XR) (Drug); Sertraline (Drug); adequate mood stabilizer (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

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.

Clinical Details

Official title: Effectiveness of Quetiapine XR Versus Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

Secondary outcome:

The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score

The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score

Number of Patients Response at Week 1

Number of Patients With Response at Week 2

Number of Patients With Response at Week 4.

Number of Patients With Response at Week 8.

Number of Patients With Remission at Week 1.

Number of Patients With Remission at Week 2.

Number of Patients With Remission at Week 4.

Number of Patients With Remission at Week 8.

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

- Hamilton Depression Rating Scale (HDRS-17) total score ≥ 20 and Young Mania Rating

Scale (YMRS) total score ≤ 14 at the screening and randomization visits - Informed

consent signed 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 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

Research Site, Santander, Cantabria, Spain

Research Site, Zamora, Castilla-León, Spain

Research Site, Vigo, Galicia, Spain

Research Site, Vitoria, Pais Vasco, Spain

Additional Information

Starting date: May 2009
Last updated: April 16, 2012

Page last updated: August 23, 2015

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