ISRCTN90111395已完成不适用
Mood stabiliser plus antidepressant versus mood stabiliser plus placebo in the maintenance treatment of bipolar disorder
niversity of British Columbia (Canada)0 个研究点目标入组 216 人开始时间: 2009年11月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients meeting all of the following criteria will be eligible for inclusion in the open-label study phase:
- •1. Diagnosed with BD, current episode depressed, with a Montgomery Asberg Depression Rating Scale (MADRS) score greater than or equal to 20 at both the screening and baseline assessments
- •2. The duration of the current depressive episode is greater than or equal to 2 weeks but less than or equal to 52 weeks
- •3. Taking or initiating treatment with a mood stabilising medication at a therapeutic dose. Mood stabilising medications and therapeutic doses are: lithium, serum level 0.6 - 1.4 mEq/L; divalproex, serum level 350 - 700 mM; risperidone 1 - 6 mg/day; olanzapine 5 - 30 mg/day; quetiapine IR or XR 300 - 900 mg/day; aripiprazole 10 - 30 mg/day; and ziprasidone 80 - 160 mg/day.
- •4. If taking any other psychoactive medication (other than lorazepam less than or equal to 4 mg/day or equivalent), is agreeable to tapering and discontinuing it over a period of less than or equal to 4 weeks
- •5. If female and of childbearing potential, is using an adequate method of contraception. Adequate methods of contraception include abstinence; oral contraceptive pill or surgically implanted device; intra-uterine device; condom plus spermicidal foam or jelly; or tubal ligation.
- •6. Aged 18 - 70 years, inclusive, either sex
- •7. Fluent in English and capable of providing informed consent
- •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 stabilising medication (lithium, serum level 0.8 - 1.2 mEq/L or divalproex, serum level 350 - 700 mM), 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), or a mood stabiliser plus a second-generation antipsychotic (SGA).
- •2. Has adequately tolerated the combination of antidepressant plus mood stabiliser, and is currently in remission for greater than or equal to 2 weeks and less than or equal to 8 weeks
- •3. If female and of childbearing potential, is using an adequate method of contraception
排除标准
- •Patients meeting any of the following criteria will be excluded from the open-label study phase:
- •1. Has a history of rapid cycling, defined as greater than or equal to 4 mood episodes in the preceding 12 months
- •2. Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a Young Mania Rating Scale (YMRS) score greater than or equal to 8 at the screening or baseline visits
- •3. Has previously been refractory to treatment with both escitalopram and bupropion XL, or has been unable to tolerate both medications due to intolerable side effects or an allergic reaction
- •4. 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.
- •5. Is at high risk for suicide, as defined by a score of greater than or equal to 3 on the suicide item of the Hamilton Depression Rating Scale (HAM-D), or in the opinion of the investigator
- •6. 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
- •7. Is pregnant or lactating
- •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 greater than or equal to 4 mood episodes in the preceding 12 months
- •2. Has current manic, hypomanic, or subsyndromal hypomanic symptoms, defined as a YMRS score greater than or equal to 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 greater than or equal to 3 on the suicide item of the HAM-D, 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. Is pregnant or lactating
- •7. Has experienced an episode of mania, hypomania, or a mixed episode during antidepressant treatment of the acute depression, defined as a YMRS score of greater than or equal to 16 at any open-label study visit, or in the opinion of the study psychiatrist
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