Lexapro for Major Depression in Patients With Epilepsy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Hamilton Depression Scale
研究概览
简要总结
The primary objective will be to pilot the use of escitalopram for the treatment of major depression in patients with epilepsy. The secondary objectives will be to determine effect sizes on scales measuring depressive symptoms, physical symptoms, psychosocial function and quality of life, and to evaluate safety in the population of patients with epilepsy.
These results will be used to evaluate the possibility of a future double-blind, placebo controlled RCT of escitalopram for the treatment of major depression in patients with epilepsy.
详细描述
Rationale:
Epilepsy is a chronic disorder that adversely affects social, vocational, and psychological functioning. Despite the variety and complexity of the negative clinical associations with epilepsy, depression is remarkable in prevalence and related adverse effects on health status. An estimated 30-50% of persons with refractory epilepsy have major depression, and depression has a stronger correlation than seizure rate with quality of life. Suicide is one of the leading causes of death in epilepsy. Available data indicate that depression may result from underlying brain dysfunction rather than social and vocational disability. Most patients with depression are not screened systematically for the diagnosis, and are subsequently not treated. Although the density of serotonin receptors is greatest in limbic brain regions commonly involved in human epilepsy, such as the mesial temporal and prefrontal areas, no prior randomized controlled trials have evaluated the efficacy of serotonin reuptake inhibitors for depression in epilepsy.
Escitalopram may be an ideal SSRI for patients on antiepileptic medications because of the lack of pharmacokinetic drug interactions, which can be expected, for example, with fluoxetine or paroxetine.
Study Hypothesis:
Epilepsy patients having major depression will improve significantly over the course of a 12-week trial with escitalopram. Significant improvement will occur in ratings of depressive symptoms, physical symptoms and measures of psychosocial function and quality of life.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be 20 males or females above the age of 18 with a current major depressive episode, as defined by DSM-IV and assessed on the MINI, of at least 4 weeks duration.
- •All subjects must have epilepsy, defined as the recurrence of seizures that are unprovoked and unpredictable, requiring treatment with an anti-epileptic medication under the care of a neurologist.
- •Subjects must be stabilized on their antiepileptic drug (AED) regimen for the previous 2 months.
- •If a vagus nerve stimulator is in place, the settings must be unchanged for the previous 2 months.
- •Patients must be ages 18 - 75 and have a 24 item Hamilton Depression Rating Scale Score (HAM-D) at intake >/=
- •Subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent.
排除标准
- •Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder(defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
- •History of psychosis, mania or hypomania.
- •Subjects with more than 10 seizures per month that involve impairment of consciousness, such as complex partial or generalized seizures.
- •Subjects unable to count seizures accurately, or do not have a someone in their home who can count seizures accurately .
- •Unstable medical or neurological disorder (other than epilepsy).
- •Epilepsies related to a progressive neurologic disease such as a brain tumor.
- •Substance abuse including ETOH within the past 6 months.
- •Need for concurrent psychotropic drugs with the exception of AEDs or zolpidem for sleep.
- •Concurrent or recent (within 3 months) entry into a new psychotherapy.
- •Actively or acutely suicidal.
- •Failure to respond to escitalopram or to two or more other adequate antidepressant trials in the past year.
- •Pregnancy or lactation.
- •Females of child bearing potential who do not practice adequate contraception.
研究组 & 干预措施
Lexapro
escitalopram 10 mg or 20 mg/d
干预措施: Lexapro (Drug)
结局指标
主要结局
Hamilton Depression Scale
时间窗: 12 weeks
Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
次要结局
- National Hospital Seizure Severity Scale(12 Weeks)