A Pilot Study Assessing Efficacy, Safety, and Tolerability of EmSam in Bipolar Depression
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Reduction of Depression CGI Score (<= 2)
研究概览
简要总结
This pilot study will evaluate the efficacy of the monoamine oxidase inhibitor (MAOI)EmSam, a selegiline transdermal system (STS), in bipolar depression.
详细描述
Most current treatments for bipolar depression have been shown to be of modest effectiveness. There is some literature which suggests that Monoamine Oxidase Inhibitors (MAOIs) have greater efficacy than tricyclic antidepressants, and that they are effective for treatment-resistant depression of all types, both unipolar and bipolar. The MAOI selegiline has demonstrated antidepressant efficacy. EmSam, a selegiline transdermal system, provides central nervous system but not intestinal/liver MAO inhibition without clinically significant increases in sensitivity to dietary tyramine. This transdermal system appears to be associated with fewer side effects and increased safety relative to oral MAOI's. This pilot study will evaluate the efficacy of EmSam in bipolar depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 - 65
- •DSM-IV Bipolar Disorder (I, II, NOS), Depressed Phase
- •DSM-IV Bipolar Disorder (I,II, NOS), Mixed state with adequate mood stabilization (ie, resolution of manic or hypomanic symptoms for 8 weeks with a minimum of 4 weeks on a stable dose of mood-stabilizing medication that will be continued through all phases of the study).
- •Prior failure of or inability to tolerate at least one other antidepressant treatment
- •Physically healthy
- •Agrees to participate in the study
- •HAM-D 24 > 10
排除标准
- •Bipolar Disorder (I, II, NOS), Mixed State without adequate mood stabilization
- •Prior significant adverse reaction to EmSam
- •Unstable medical disorder
- •History of epilepsy (febrile seizure o.k.)
- •Current use of any medication that might interact with EnSam.
- •Use within 2 weeks of other antidepressant medication (6 weeks for fluoxetine)
- •Inability to adhere to a tyramine-free diet
- •Recent (past 6 months) suicide attempt
- •Serious suicidal ideation
- •Breast feeding
- •Fecund, sexually active females, without adequate contraception
- •Prior failure to respond to 2 or more adequate oral MAOI trials (2/3 PDR maximum dose, minimum 4 weeks)
- •Non-nicotine substance abuse/dependence within the past 6 months (1 year for amphetamines/cocaine)
研究组 & 干预措施
EmSam
EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.
干预措施: EmSam (Drug)
结局指标
主要结局
Reduction of Depression CGI Score (<= 2)
时间窗: 8 weeks
HAM-D score. Young Mania Scale Life Chart Method Patient Global Impression Symptom Checklist - 90 Quality of Life Enjoyment and Satisfaction Questionnaire 0 participants analyzed due to early termination of study.
次要结局
未报告次要终点