Quetiapine in the Treatment of Postpartum Depression (PPD) in Bipolar Disorder (BD), Type II

Inclusion Criteria:

• signed informed consent;
• women, 19 - 40 years;
• meets Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria of Bipolar II Disorder (confirmed by Mini International Neuropsychiatric Interview (MINI));
• Hamilton Depression Rating Scale (HAM-D) (17-item) total score of > 22 and HAM-D item 1 (depressed mood) score of >2 at Visit 1 (enrolment) & Visit 2;
• negative serum pregnancy test at enrolment, use reliable method of birth control (i.e. barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation) during study;
• understand and comply with requirements of study
• outpatient status at enrolment.

Exclusion Criteria:

• DSM-IV Axis I disorder other than Bipolar II Disorder within 6 months of enrolment;
• diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status;
• substance or alcohol abuse or dependence within 6 months prior to enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined in DSM-IV criteria;
• Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment;
• use of drugs that induce or inhibit the hepatic metabolizing cytochrome P450 3A4 enzymes within 2 weeks prior to Visit 2;
• pregnancy or lactation;
• evidence of clinically relevant disease, e.g., renal or hepatic impairment, significant coronary artery disease, cerebrovascular disease, viral hepatitis B or C, acquired immunodeficiency syndrome (AIDS);
• clinical finding that is unstable or inadequately treated, (e.g., hypertension, poorly controlled diabetes, unstable angina) or that would be negatively affected by the study medication or affect the study medication;
• medical conditions that would affect absorption, distribution, metabolism, or excretion of study medication (e.g., malabsorption syndrome, liver disease);
• current diagnosis of cancer (except basal or squamous cell skin carcinoma) unless in remission for at least 5 years;
• current or past diagnosis of stroke or Transient Ischemic Attacks (TIA);
• history of seizure disorder, except febrile convulsions;
• receipt of electroconvulsive therapy (ECT) within 90 days prior to Visit 2;
• use of antipsychotic, mood stabilizer, or antidepressant drugs within 7 days before Visit 2, or use of fluoxetine within 28 days before Visit 2, or use of monoamine oxidase inhibitors (MAOIs), anxiolytic or hypnotics within 14 days before Visit 2 (with the exception of those allowed with restriction per protocol), or use of a depot antipsychotic injection within 2 dosing interval before Visit 2;
• subjects who will require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to Visit 2;
• subjects who pose a current serious suicidal or homicidal risk, have a HAM-D item 3 score of 3 or greater, or have made a suicide attempt within the past 6 months;
• a patient with Diabetes Mellitus (DM) fulfilling specific criteria as judged by the investigator that would make her unable to participate;
• clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator;
• an absolute neutrophil count (ANC) of <1.5 x 109 per liter;
• a thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the patient is being treated for hypothyroidism;
• liver function tests aspartate aminotransferase (AST) or alanine aminotransferase (ALT) three times the upper normal limit;
• Electrocardiogram (ECG) results considered being clinically significant based on assessment by a centrally located experienced cardiologist interpreting the ECG;
• use of quetiapine in doses greater than 25mg/day for insomnia within 7 days before Visit 2;
• known history of intolerance or hypersensitivity to quetiapine;
• known lack of response to quetiapine in the treatment of depression in a dosage of at least 50 mg per day for 4 weeks (at any time before study start);
• treatment with quetiapine with a dosage of at least 50 mg/day at Visit 1 (enrolment);
• contraindications as detailed in the country-specific prescribing information for quetiapine;
• involvement in the planning and conduct of the study;
• previous enrolment in any AstraZeneca-sponsored study with quetiapine;
• participation in another clinical study or compassionate use programme within 4 weeks of Visit 2 or longer in accordance with local requirements.