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

NCT ID: NCT00857584

Last Updated: 2012-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-02-28

Brief 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.

Conditions

Bipolar Disorder; Bipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quetiapine Extended Release

Lithium or valproate at stable doses within seric therapeutic levels

Group Type: EXPERIMENTAL

Extended release quetiapine (quetiapine XR)

Intervention Type: DRUG

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.

adequate mood stabilizer

Intervention Type: DRUG

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).

Sertraline

Lithium or valproate at stable doses within seric therapeutic levels

Group Type: ACTIVE_COMPARATOR

Sertraline

Intervention Type: DRUG

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.

adequate mood stabilizer

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

SEROQUEL XR®; Zoloft

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Vitoria-Gasteiz, Basque Country, Spain

Research Site

Santander, Cantabria, Spain

Research Site

Zamora, Castille and León, Spain

Research Site

Vigo, Galicia, Spain

Countries

Spain

Other Identifiers

D1443L00058

Identifier Type: -

Identifier Source: org_study_id