Mood Stabilizer Plus Antidepressant versus Mood Stabilizer Plus Placebo in the Maintenance Treatment of Bipolar Disorder

Canadian Institutes of Health Research0 个研究点目标入组 156 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients meeting all of the following criteria will be eligible to be included in the double-blind study phase:
•1.Taking escitalopram 10-30 mg/day or bupropion XL 150-450 mg/day, in addition to either a mood stabilizing medication (lithium, serum level 0.6-1.2 mEq/L, divalproex, serum level 350-700 mM or carbamazepine, serum level 20-50 umol/L), an SGA (risperidone 1-6 mg/day; olanzapine 5-30 mg/day; quetiapine IR or XR 150-900 mg/day; aripiprazole 10-30 mg/day; or ziprasidone 80-160 mg/day), two mood stabilizers, a mood stabilizer plus an SGA (including asenapine 5-20 mg/day), or a mood stabilizer or SGA plus lamotrigine (100-400 mg/day).
•2.Has adequately tolerated the combination of antidepressant plus mood stabilizer, and is currently in remission for >= 2 weeks and <= 8 weeks.
•3.If female and of childbearing potential, is using an adequate method of contraception.

•Patients meeting any of the following criteria will be excluded from the double-blind study phase:
•1.Has a history of rapid cycling, defined as >= 4 mood episodes in the preceding 12 months.
•2.Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a YMRS score >= 8 at the screening or baseline visits.
•3.Has active substance dependence, other than caffeine or nicotine dependence, in the preceding 3 months. Otherwise, patients with comorbid substance abuse or other comorbid psychiatric illnesses will be eligible to participate in the study.
•4.Is at high risk for suicide, as defined by a score of >= 4 on the suicide item of the MADRS, or in the opinion of the investigator.
•5.Has an unstable medical illness, as defined by a change in medication or other treatment in the past 4 weeks, or in the opinion of the investigator.
•6.Has significant abnormalities on an electrocardiogram.
•7.Is pregnant or lactating.
•8.Has experienced an episode of mania, hypomania, or a mixed episode during antidepressant treatment of the acute depression, defined as a YMRS score of >= 16 at any open-label study visit, or in the opinion of the study psychiatrist.

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