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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00883493Tipo: INTERVENTIONALInicio: 1 de abr de 2009Fin estimado: 1 de mar de 2011

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Quetiapine fumarate XR

Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.

drug

Lithium carbonate

Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day

Ubicaciones

Research Site

La Plata, Buenos Aires, Argentina

Research Site

Godoy Cruz, Mendoza Province, Argentina

Research Site

Mendoza, Mendoza Province, Argentina

Research Site

Caba, Argentina

Patrocinadores

PrincipalAstraZeneca

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