NCT00296179已完成4 期
Comparison of Zolpidem Tartrate Extended-Release vs. Placebo in Treatment of Insomnia Associated With Newly Diagnosed Major Depressive Disorder(MDD) or Untreated MDD Relapse, When Used Concomitantly With Escitalopram
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
- 主要终点
- Efficacy: Patient-reported TST
研究概览
简要总结
To demonstrate overall improvement of insomnia in subjects treated with zolpidem tartrate extended-release (Ambien CR) and escitalopram (Lexapro) vs. subjects treated with placebo and escitalopram at 2 months.
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
- •MAJOR INCLUSION CRITERIA:
- •Must experience sleep disturbances at least 3 nights/week, based on historical data
- •Must meet the diagnostic requirements for Major Depressive Disorder
- •Must have QIDS-SR16 score between 6 and 15
- •Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication
- •Age 21-64, inclusive
- •Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) 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.
- •Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit.
排除标准
- •Severity of depressive episode had been rated as "severe" or "severe with psychotic features."
- •History of a suicide attempt or suicidal ideation.
- •History of mania, manic episode or bipolar disease.
- •Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization.
- •Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag
- •Any abnormal pre-study laboratory values that require clinical intervention
- •Prior failure to respond to escitalopram therapy for depression
- •Current depressive episode requiring inpatient hospitalization.
- •Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days.
- •History of drug addiction, alcoholism, or drug abuse.
- •A positive urine drug screen for medication that would interfere with the assessment of the study medication.
- •Known allergy to zolpidem, escitalopram or any of their excipients
- •History of sleep apnea
- •History of myasthenia gravis
- •The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy.
- •Pregnant or breastfeeding
- •Subject is participating in another clinical trial, or has completed another clinical trial within 28 days prior to screening.
结局指标
主要结局
Efficacy: Patient-reported TST
次要结局
- Difference in relapse rates in patients receiving placebo and patients receiving zolpidem MR during 4 month follow-up period
研究者
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