KCT0001192招募中未知
Mood Stabilizer Plus Antidepressant versus Mood Stablizer Plus Placebo in the Maintenance Treatment of Bipolar Disorder
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. Open-label phase
- •1) Diagnosed with BD, current episode depressed, with a MADRS score =
- •20 at both the screening and baseline assessments.
- •2) The duration of the current depressive episde is = 2 weeks but = 52
- •3) Taking or initiating treatment with an anti-manic medication at a
- •therapeutic dose. Anti-manic 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. Combinations of these medications as outlined above, or
- •the combination of any of them with Lamotrigine 100-400 mg daily,
- •or the combination of a mood stabilizer plus Asenapine, 5-20
- •mg/day, are also permitted.
- •4) If taking any other psychoactive medication(other than Lorazepam =
- •4 mg/day or equivalent), is agreeable to tapering and discontinuing
- •it over a period of = 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) Fluent in Korean and capable of providing informed consent.
- •7) Aged 18-70 years, inclusive.
- •2. Double-blind 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, Carbamazepine, serum level 20-
- •50 umol/L), a second generation antipsychotics(Risperidone 1-6 mg/day;
- •Olanzapine 5-30 mg/day; Quetiapine IR or XR 150-900 mg/day; Aripiprazole 10-
- •30 mg/day; Ziprasidone 80-160 mg/day), two mood stabilizers, a mood
- •stabilizer plus a second generation antipsychotics (including Asenapine 5-
- •20 mg/day), or a mood stabilizer or second generation antipsychotics 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 =
- •3) If female and of childbearing potential, is using an adequate
- •method of contraception.
排除标准
- •1. Open-label phase
- •1) Has a history cycling, defined as = 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 = 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 = 4 on the
- •suicide item of the MADRS, or in the opinion of the investigator.
- •6) Has an unstable meidcal 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.
- •8) Is taking monoamine oxidase inhibitors, such as Phenelzine or
- •Tranylcypromine.
- •9) Escitalopram is contraindicated in patients taking the
- •antipsychotic medications Pimozide or Ziprasidone. Patients on
- •Pimozide or Ziprasidone can participate in the study and will be
- •prescribed Bupropion XL.
- •10) Bupropion XL is contraindicated in patients taking other
- •preparations containing Bupropion, such as Zyban and Wellbutrin SR;
- •in patients with active eating disorders, including anorexia
- •nervosa and bulimia nervosa; and in patients with seizure
- •disorders. Patients with any of these can still participate in the
- •study and will be prescribed Escitalopram.
- •11) Has significant abnormalities on an electrocardiogram.
- •2. Double-blind phase
- •1) The criteria are the same as open-label phase. In addition,
- •patients have experienced an episode of mania, hypomania, or a
- •mixed episode during antidepressant treatment of the acute
- •depression, defined as a YMRS score of = 16, or in the opinion of
- •the study psychiatrist.
研究者
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