Efficacy of Quetiapine XR Versus Divalproex on Clinical Outcome Quality of Sleep and Quality of Life in Bipolar Depression

Inclusion Criteria:

• Provision of written informed consent
• A diagnosis of Bipolar depression by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
• Females and males aged 20 to 65 years
• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrollment
• Able to understand and comply with the requirements of the study
• HAM-D score at Visit 0 and Visit 1 should be above 20.
• Willingness to adhere to the schedule of assessments
• Able and willing to comply with self-administration of study drug, or have consistent help or support available

Exclusion Criteria:

• Pregnancy or lactation
• Any DSM-IV Axis 1 disorder not defined in the inclusion criteria
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• Known intolerance or lack of response to quetiapine fumarate or divalproex, as judged by the investigator
• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erγthromycin， clarithromycin, troleandomycin, indinavir, nelfinavir，ritonavir, fluvoxamine and saquinavir
• Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin， St. John's Wort, and glucocorticoids
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
• Substance or alcohol dependence at enrollment (except dependence in full remission,and except for caffeine or nicotine dependence) ， as defined by DSM-IV criteria
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 8 weeks prior to enrollment
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
• Unstable or inadequately treated medical illness (e,g, congestive heart failure,angina pectoris, hypertension) as judged by the investigator Invo1vement in the planning and conduct of the study
• Previous enrollment or randomisation of treatment in the present study.
• Participation in another drug trial within 8 weeks prior enrollment into this study or longer in accordance with local requirements

A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

• Unstable DM defined as enrolment glycosylated hemoglobin (HbAlc) > 8.5%
• Admitted to hospital for treatment of DM or DM related illness in past 12 weeks
• Not under physician care for DM
• Physician responsib1e for patient's DM care has not indicated that patient's DM is controlled
• Physician responsible for patient's DM care has not approved patient's participation in the study
• Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks

• Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study

  • An absolute neutrophil count (ANC) of s 1.5 x 109 per liter