NCT00595699已完成4 期
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-blind, Placebo-controlled Study.
Conrad, Erich J., M.D.1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Montgomery And Asberg Depression Rating Scale
研究概览
简要总结
This is a research study evaluating the use of escitalopram (Lexapro®) for the treatment of major depression in subjects with temporal lobe epilepsy. The purpose of the study is to measure the severity and change in depressive and anxiety symptoms after 10 weeks of study treatment with escitalopram or placebo as measured by certain rating scales and questionnaires. In addition, the study will measure the frequency of seizures using a patient diary during the study. Finally, the study will assess the change in the quality of life using rating scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Subject has a confirmed diagnosis of temporal lobe epilepsy
- •Subject meets DSM-IV criteria for Major Depression
- •MADRS greater than or equal to 15 at screening and baseline
- •Subject between ages of 18 and 65
- •Female subjects of childbearing potential must take adequate contraceptive precautions (methods with a published failure rate of less than 1% per year, or condom/diaphragm, or diaphragm/spermicide)
- •Subject must provide voluntary signed informed consent approved by the Institutional Review Board of LSU Health Sciences Center
排除标准
- •Any other primary axis I diagnosis other than Major Depression
- •The presence of psychogenic, non-epileptic seizures
- •A history of non-response to two or more antidepressants given for an adequate therapeutic trial
- •The presence of substance abuse or dependence in past six months
- •The presence of clinically significant malnutrition, cardiac, hepatic or renal disease that might endanger the safety of the subject
- •Pregnancy or nursing
- •Any subjects with suspected mental retardation, psychotic disorder or dementia
- •Subjects whose anticonvulsant medication regimen includes phenobarbital
- •Individuals who will require psychotropic medications such as benzodiazepines or medications likely to cause significant effects on mood or anxiety as outlined in section 5.4
- •Cognitive-behavioral therapy will not be allowed during the course of the study. Other psychotherapeutic modalities (supportive, psychoanalytic, etc.) will be allowed only if the individual has been in therapy for the previous 12 weeks and plans to remain in therapy throughout the duration of the study.
- •Individuals who in the opinion of the investigator would not be able to understand or comply with study requirements
- •Individuals with a known hypersensitivity to escitalopram or any of its ingredients
- •Individuals who in the opinion of the investigator present a significant risk of suicide, or have had a significant suicide attempt in the past two years.
研究组 & 干预措施
2
Placebo Comparator
Double-blind
干预措施: placebo (Drug)
1
Experimental
escitalopram group
干预措施: escitalopram (Drug)
结局指标
主要结局
Montgomery And Asberg Depression Rating Scale
时间窗: Screen, Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10
次要结局
- Clinician's Global Impression Severity and Improvement subscales(Baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10)
研究者
研究点 (1)
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