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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder; Bipolar Depression

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857584

D1443L00058

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Quetiapine Extended Release

Experimental group

Description:

Lithium or valproate at stable doses within seric therapeutic levels

Treatment:

Drug: Extended release quetiapine (quetiapine XR)

Drug: adequate mood stabilizer

Sertraline

Active Comparator group

Description:

Lithium or valproate at stable doses within seric therapeutic levels

Treatment:

Drug: Sertraline

Drug: adequate mood stabilizer