Randomised, double-blind, parallel-group, placebo-controlled, and active referenced study of Lu AA34893 to evaluate the efficacy and safety of three doses Lu AA34893 and quetiapine versus placebo in the treatment of depression in patients with Bipolar I or II Disorder

H. Lundbeck a/s0 个研究点目标入组 600 人开始时间: 2007年11月26日最近更新: 2012年3月19日

研究概览

暂无简介。

•·The patient fulfils the DSM-IV-TR criteria of a current major depressive episode of Bipolar Disorder I or Bipolar Disorder II, lasting for at least 30 days before screening
•·The patient has a documented history of at least one manic and/or hypomanic episode within the past 15 years.
•·The patient has a MADRS total score of 26 or higher and a YMRS total score of 8 or less at screening and baseline visits.
•·The patient is a man or woman, aged between 18 and 65 years (extremes included),
•·The patient is an in-patient in a psychiatric hospital or an out-patient at a psychiatric setting.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•·Any current psychiatric disorder other than Bipolar Disorder established as the principal diagnosis as defined in the DSM-IV-TR or any other current neurological disorder other than Bipolar Disorder
•·Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
•·The patient has a history of very rapid cycling
•·The patient has, in the Investigator’s opinion, a significant risk of suicide
•·The patient has received quetiapine in doses of 50 mg/day or above as treatment for the current depressive episode
•·The patient’s current depressive episode has been non-responsive to two or more adequate antidepressant treatments of at least 6 weeks duration
•·The patient’s current depressive episode has been non-responsive to two or more antipsychotic treatments of at least 6 weeks duration
•·The patient is currently treated or has been treated within 2 weeks prior to randomisation with one or more mood stabilisers, lamotrigine, anti-psychotic or antidepressive drugs.
•The patient requires ECT or has received ECT within the last 6 months.
•·The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study.

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