study to evaluate the effects of switching different strength forms of fk949e in bipolar disorder patients with major depressive episodes

Conditions: Bipolar Depression

Summary: the purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching fk949e (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar disorder patients with major depressive episodes.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar i or ii disorder as specified in the diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr), with a major depressive episode. * able to participate in the study with understanding of and compliance with subject requirements during the study in the investigator's or subinvestigator's opinion. exclusion criteria: * concurrent or previous history of dsm-iv-tr axis i disorders, except bipolar disorder, within the last 6 months before informed consent. * concurrence of dsm-iv-tr axis ii disorder that is considered to greatly affect patient's current mental status. * the young mania rating scale (ymrs) total score of 13 points or more. * nine or more mood episodes within the last 12 months before informed consent. * lack of response to at least 6-week treatment with at least 2 antidepressants for the current major depressive episode in the investigator's or subinvestigator's opinion. * the current major depressive episode persisting for less than 4 weeks before informed consent. * history of substance dependence (other than caffeine and nicotine) or alcohol abuse or dependence. * treatment with a depot antipsychotic within the last 49 days before the start of the pre-treatment observation period. * unable to suspend antipsychotics or antidepressants after the start of the pre-treatment observation period. * treatment with more than one of the following three drugs, mood stabilizers (lithium carbonate and/or sodium valproate) and lamotrigine, if these drugs, except one of either drugs, cannot be suspended after the start of the pre-treatment observation period. * unable to suspend antiepileptics (except lamotrigine and sodium valproate), antianxiety agents, hypnotics, sedatives, psychostimulants, antiparkinsonian agents, cerebral ameliorators, antidementia agents, or anorectics, except those specified as conditionally-allowed concomitant drugs, from 7 days before the start of the pre-treatment observation period. * unable to suspend cyp3a4 inhibitors or inducers, or monoamine oxidase (mao) inhibitors from 7 days before the start of the pre-treatment observation period. * electroconvulsive therapy within the last 83 days before the start of the pre-treatment observation period. * a possible need of psychotherapy during the study period (unless the therapy has been commenced at least 83 days before the start of the pre-treatment observation period). * the hamilton depression rating scale (ham-d17) suicide score of 3 points or more, history of suicide attempt within the last 6 months before informed consent, or the risk of suicide in the investigator's or subinvestigator's opinion.

Keywords: major depressive episodes fk949e quetiapine bipolar depression bipolar disorder