NCT00296790已完成4 期
Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Evaluate safety and hypnotic efficacy of zolpidem tartrate extended release vs. placebo in treatment of insomnia associated with Generalized Anxiety Disorder when used concomitantly with escitalopram
研究概览
简要总结
A comparison of Zolpidem Tartrate Extended-Release (Ambien CR)vs. Placebo in the Treatment of Insomnia Associated with Generalized Anxiety Disorder (GAD) when Used Concomitantly with Escitalopram (Lexapro - antidepressant).
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
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 21and 64 years, inclusive;
- •Women must use a medically acceptable form of contraception during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization;
- •Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders;
- •Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A)
- •Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety.
- •Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data.
- •Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry.
- •History of Post-Traumatic Stress Disorder;
- •Concomitant Major Depressive Disorder or Bipolar Disorder;
- •Any abnormal pre-study laboratory values that require clinical intervention
- •Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month.
- •Pregnant or breastfeeding
- •History of drug addiction, alcoholism, or drug abuse
- •Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
- •A positive urine drug screen for compounds that would interfere with the assessment of a hypnotic.
- •Use of prescription and non-prescription sedative drugs;
- •Prior failure to respond to escitalopram therapy for anxiety
- •The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
- •History of sleep apnea
- •History of myasthenia gravis
- •Known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients
- •Subject is currently participating in another clinical trial (or within 28 days of screening).
排除标准
- 未提供
结局指标
主要结局
Evaluate safety and hypnotic efficacy of zolpidem tartrate extended release vs. placebo in treatment of insomnia associated with Generalized Anxiety Disorder when used concomitantly with escitalopram
次要结局
- To show that treating insomnia from beginning of SSRI (Selective Serotonin Reuptake Inhibitor) treatment for anxiety results in improvement in quality of life and possibly greater response to anti-anxiety therapy
研究者
研究点 (1)
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