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

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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)

27 participants in 2 patient groups

Quetiapine Extended Release
Experimental group
Description:
Lithium or valproate at stable doses within seric therapeutic levels
Treatment:
Drug: adequate mood stabilizer
Drug: Extended release quetiapine (quetiapine XR)
Sertraline
Active Comparator group
Description:
Lithium or valproate at stable doses within seric therapeutic levels
Treatment:
Drug: adequate mood stabilizer
Drug: Sertraline

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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