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 MentalDisorders- Fourth Edition (DSM-IV)

• Females and males aged 20 to 65 years

• Female patients of childbearing potential must be using a reliable method ofcontraception and have a negative urine human chorionic gonadotropin (HCG) test atenrollment

• 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 consistenthelp 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 ora danger to self or others

• Known intolerance or lack of response to quetiapine fumarate or divalproex, as judgedby the investigator

• Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days precedingenrollment 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 precedingenrollment 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 thedepot) before randomisation

• Substance or alcohol dependence at enrollment (except dependence in full remission,andexcept for caffeine or nicotine dependence) ， as defined by DSM-IV criteria

• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IVcriteria within 8 weeks prior to enrollment

• Medical conditions that would affect absorption, distribution, metabolism, orexcretion of study treatment

• Unstable or inadequately treated medical illness (e,g, congestive heart failure,anginapectoris, hypertension) as judged by the investigator Invo1vement in the planning andconduct 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 orlonger 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 iscontrolled

• Physician responsible for patient's DM care has not approved patient's participationin the study

• Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4weeks prior to randomisation. For thiazolidinediones (glitazones) this period shouldnot 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 diabeticpatient meets one of these criteria, the patient is to be excluded even if thetreating physician believes that the patient is stable and can participate in thestudy

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