A Double-Blind, Randomized, Parallel Group, Placebo- Controlled Sleep Laboratory Efficacy and Safety Study With Org 50081 in Elderly Subjects With Chronic Primary Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 538
- 主要终点
- Average Wake Time After Sleep Onset Measured by Polysomnography
研究概览
简要总结
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine)
compared to placebo in elderly participants with chronic primary
insomnia. Primary efficacy variable is Wake time After Sleep
Onset (WASO), averaged over all in-treatment time points
and measured by polysomnography (PSG).
详细描述
Insomnia is a common complaint or disorder throughout the
world. About one third of the population in the industrial
countries reports difficulty initiating or maintaining sleep,
resulting in a non-refreshing or non-restorative sleep. The
majority of the insomniacs suffer chronically from their
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are at least 65 years of age at screening;
- •sign written informed consent after the scope and
- •nature of the investigation have been explained to
- •them, before screening evaluations;
- •are able to speak, read and understand the language of
- •the investigator, study staff (including raters) and the
- •informed consent form, and possess the ability to
- •respond to questions, follow instructions and complete
- •questionnaires;
- •have demonstrated capability to independently
- •complete the LogPad questionnaires and have
- •completed the questionnaires at least 6 out of 7 days of
- •the week preceding randomization;
- •have a regular sleep pattern, meaning bedtime regularly
- •occurs between 2100 hours and 2400 hours, with no more variation
- •from these boundaries than 2 times/ week, with 5-8.5
- •hours in bed;
- •have a documented diagnosis of chronic primary
- •insomnia, defined as fulfillment of the Diagnostic and Statistical Manual of Mental Disorders IV - Text Revision (DSM-IV-TR) criteria
- •for primary insomnia (DSM-IV-TR 307.42) with a duration
- •of >= 1 month; fulfill the following PSG criteria on the
- •two screening/baseline PSG nights:
- •average Total Sleep Time (TST) < 6.5 h (and each night greater than or
- •equal to 3 h and < 7 h),
- •average WASO greater than or equal to 45 minutes
- •(and each night greater than or equal to 30 min),
- •average Latency to Persistent Sleep (LPS) 15 min (and each night greater than or
- •equal to 10 min).
排除标准
- •have other sleep disorders (DSM-IV-TR), such as sleep
- •related breathing disorders Apnea-Hypopnea Index (AHI) greater than or equal
- •to 15), Periodic Leg Movements with Arousals Index (PLMAI)
- •greater than or equal to 10), restless leg syndrome,
- •narcolepsy, circadian sleep wake rhythm disorders,
- •Rapid Eye Movement (REM) behavioral disorder or any parasomnia;
- •have any significant medical or DSM-IV-TR
- •psychiatric illness causing the sleep disturbances;
- •currently meet diagnostic criteria for DSM-IV-TR
- •depression Major Depressive Disorder (MDD) or have been diagnosed and treated
- •for MDD within the last 2 years;
- •have a history of bipolar disorder, a history of suicide attempt or a family history of suicide. A family history of suicide is defined as any history of suicide in the first and second degree family (parents, siblings, grandparents, or offspring), or a pattern of completed suicides (more than one) in the third degree family (aunts, uncles, nieces and nephews);
- •have a history or signs of dementia or other serious
- •cognitive impairment, as defined by a score of less than
- •26 on the Mini-Mental State Examination;
- •have a significant, unstable medical illness e.g. acute or
- •chronic pain, hepatic, renal, metabolic or cardiac
- •had serious head injury or stroke within the past year,
- •or a history of (non-febrile) seizures;
- •have clinically relevant electrocardiogram (ECG) abnormalities at
- •screening, as judged by the investigator;
- •have clinically relevant abnormal hematology or
- •biochemistry values at screening, as judged by the
- •investigator;
- •have DSM-IV-TR substance abuse or DSM-IV-TR
- •addiction within the last year;
- •drink more than 2 alcoholic drinks in a day. One drink is approximately equal to: 12 oz or 360 ml of beer (regular or light), or 4 oz or 120 ml of red or white wine, or 2 oz or 60 ml of desert wine (e.g. port, sherry), or 12 oz or 360 ml of wine cooler (regular or light), or 1 oz or 30 ml or spirits (80 to 100 proof, e.g. whiskey, vodka);
- •are routinely sleeping during daytime (napping) for more than 20 minutes per day, 3 days or more per week;
- •are night workers or rotating shift workers currently, or in the past 6 months
- •use of psychotropic drugs affecting sleep within two weeks prior to randomization (fluoxetine: five weeks);
- •use of concomitant medication affecting sleep (e.g. anxiolytics, sedatives, antidepressants, antipsychotics, centrally active sedating antihistamines, central nervous system (CNS)
- •stimulants, alpha-2-antagonists, respiratory stimulants and decongestants);
- •smoke > 15 cigarettes per day and/or can not abstain from smoking during the night;
- •drink excessive amounts of caffeinated beverages/day (more than 500 mg caffeine per day);
- •have a body mass index (BMI) >= 36;
- •have a positive urine drug screen at screening or at baseline;
- •have a known hypersensitivity to mirtazapine or to any of the excipients;
研究组 & 干预措施
Esmirtazapine 0.5 mg
one placebo tablet daily for 14 days, followed by one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
干预措施: Esmirtazapine (Drug)
Esmirtazapine 0.5 mg
one placebo tablet daily for 14 days, followed by one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
干预措施: Placebo (Drug)
Esmirtazapine 1.5 mg
one placebo tablet daily for 14 days, followed by one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
干预措施: Esmirtazapine (Drug)
Esmirtazapine 1.5 mg
one placebo tablet daily for 14 days, followed by one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
干预措施: Placebo (Drug)
Esmirtazapine 3.0 mg
one placebo tablet daily for 14 days, followed by one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
干预措施: Esmirtazapine (Drug)
Esmirtazapine 3.0 mg
one placebo tablet daily for 14 days, followed by one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
干预措施: Placebo (Drug)
Placebo
one placebo tablet daily for 14 days, followed by one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Average Wake Time After Sleep Onset Measured by Polysomnography
时间窗: Up to Day 16
Wake time after sleep onset (WASO) is the total time awake between sleep onset and "lights on"; i.e. from the onset of persistent sleep until the end of the 8-hour polysomnography (PSG) recording. PSG assesses the quality of sleep by monitoring brain waves, breathing, heart function, muscle activity and eye movement. PSG measurements of WASO (observed data only) taken during the 16-day double-blind treatment period, over days 1 and 2 and days 15 and 16, were averaged.
次要结局
- Average Total Sleep Time Measured by Polysomnography(Up to Day 16)
- Average Latency to Persistent Sleep Measured by Polysomnography(Up to Day 16)
- Average Number of Awakenings Measured by Polysomnography(Up to Day 16)
- Average Wake Time After Sleep Onset in the First Quarter of the Night Measured by Polysomnography(Up to Day 16)
- Average Wake Time After Sleep Onset in the Second Quarter of the Night Measured by Polysomnography(Up to Day 16)
- Average Wake Time After Sleep Onset in the Third Quarter of the Night Measured by Polysomnography(Up to Day 16)
- Average Wake Time After Sleep Onset in the Fourth Quarter of the Night Measured by Polysomnography(Up to Day 16)
- Average Number of Stage Shifts to Stage 1 or Wake Measured by Polysomnography(Up to Day 16)
- Average Subjective Total Sleep Time Based on Sleep Diary(Up to Day 16)
- Average Subjective Sleep Latency Based on Sleep Diary(Up to Day 16)
- Average Subjective Number of Awakenings Based on Sleep Diary(Up to Day 16)
- Average Subjective Wake Time After Sleep Onset Based on Sleep Diary(Up to Day 16)
- Average Subjective Quality of Sleep Based on Sleep Diary(Up to Day 16)
- Average Subjective Satisfaction of Sleep Duration Based on Sleep Diary(Up to Day 16)
- Number of Participants With an Adverse Event During the 16 Day, Double-blind Treatment Period(Up to Day 16)
- Number of Participants Who Discontinued Treatment Due to an Adverse Event During the 16 Day, Double-blind Treatment Period(Up to Day 16)