study to evaluate safety and tolerability of fk949e in patients with major depressive disorder

Conditions: Major Depressive Disorder Patients

Summary: the objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of fk949e (extended-release formulation of quetiapine) in patients with major depressive disorder (mdd).

this is a dose-titration study. in low-dose-group, patients receive prescribed dose on day 5 after 3-step dose increases. in high-dose-group patients receive prescribed dose on day 7 after 4-step dose increases. patients receive prescribed dose of fk949e for 7 days in each group. the dosage period is 12 days in low dose group and 14 days in high dose group.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder according to the dsm-iv-tr (text revision of the diagnostic and statistical manual of mental disorders version-4) * female patients of childbearing potential with a negative serum pregnancy test result and who were willing and able to use a reliable method of birth control during the study * patients who could understand and comply with the requirements of the study, as judged by the investigator/sub-investigator exclusion criteria: * a current or past history of a dsm-iv-tr axis i disorder other than major depressive disorder within 6 months prior to the study * diagnosis of a dsm-iv-tr axis ii disorder that was considered to have a major impact on the patient's current psychiatric status * a history of substance or alcohol abuse or dependence excluding caffeine and nicotine * patients who were unable to abstain from drugs that induce or inhibit the drug-metabolizing enzyme cyp3a4 from 14 days prior to the start of study drug administration and throughout the study period * pregnant or lactating women * patients showing evidence or signs of renal or hepatic failure, serious heart disease, cerebrovascular disease, viral hepatitis b or c, or acquired immunodeficiency syndrome (aids) (carrier) * a clinical finding that in the opinion of the investigator/sub-investigator could be negatively affected by the study or that would affect the study results (e.g., hypertension, unstable angina) * conditions that could affect absorption and metabolism of the study medication (e.g., malabsorption syndrome, liver disease) * a current diagnosis of malignant tumor unless in remission for at least 5 years (except basal or squamous cell skin carcinoma) * a current or past diagnosis of transient ischemic attack (tia) * a history of seizure disorder, except for febrile convulsions * application of electroconvulsive therapy within 90 days prior to the start of study drug administration * use of a depot antipsychotic injection and inability to be off the drug for a period of twice the dosing interval prior to the start of study drug administration and throughout the study period * patients could require psychotherapy (other than supportive psychotherapy) during the study period, unless psychotherapy had been ongoing for a minimum of 90 days prior to the start of study drug administration * a score of ≥ 3 on the ham-d17 item (suicide) or a suicide attempt within the past 6 months, and those judged to be at serious suicidal or homicidal risk in the opinion of the investigator/sub-investigator * a current or past history of diabetes mellitus\* or glycated hemoglobin (hba1c) of ≥ 6.5% at screening within 2 months before the start of study drug administration (\*refer to the guidelines for monitoring blood glucose levels in patients treated with atypical antipsychotics) * a white blood cell count (wbc) of ≤ 3,000/mm3 at screening assessment * elevation of aspartate aminotransferase (ast) or alanine aminotransferase (alt) values at screening assessment (grade 2 or higher according to the "criteria for classification of the grade of adverse drug reactions to pharmaceutical products" (pharmaceutical affairs bureau safety division's notification no. 80 issued on 29 june 1992)) * a known history of hypersensitivity to quetiapine or to any other component in the fk949e tablets at the time of providing written informed consent * treatment with quetiapine for depressive symptoms or bipolar disorder (mania) at the time of providing written informed consent * participation in another clinical study or post-marketing study within 12 weeks prior to the start of study drug administration

Keywords: fk949e antipsychotic quetiapine