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Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression | Clinical Trials | Clareo Health

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Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression

A Randomised, Multi-Centre Study to Compare the Efficacy and Safety of Extended Release Quetiapine Fumarate (Seroquel XR TM) Tablets as Mono-Therapy or in Combination With Lithium in the Treatment of Patients With Acute Bipolar Depression

NCT00883493•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar disorder II with the most recent episode depressed
•The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20
•The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12

Exclusion Criteria

•Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk
•Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation
•Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug

Locations (24)

Research Site

La Plata, Buenos Aires, Argentina

Research Site

Godoy Cruz, Mendoza Province, Argentina

Research Site

Mendoza, Mendoza Province, Argentina

Research Site

Caba, Argentina

Research Site

Aparecida de Goiânia, Goiás, Brazil

Research Site

Rio de Janeiro, Rio de Janeiro, Brazil

Research Site

São Paulo, São Paulo, Brazil

Research Site

Santiago, Chile, Chile

Research Site

Medellín, Antioquia, Colombia

Research Site

Bogota D.c, Cundinamarca, Colombia

Key Dates

Start Date

April 1, 2009

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

July 11, 2012

Enrollment

421

ACTUAL participants

Conditions

Acute Bipolar Depression

Interventions

Quetiapine fumarate XR

DRUG

Lithium carbonate

DRUG