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临床试验/NCT00518986
NCT00518986已完成4 期

Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome With Major Depressive Disorder or Dysthymic Disorder

Cephalon57 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2007年10月最近更新:
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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
249
试验地点
57
主要终点
Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of the study is to evaluate whether armodafinil at a target dosage of 200 mg/day is more effective than placebo treatment in improving excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) who have comorbid major depressive disorder or dysthymic disorder.

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

  • •Current diagnosis of obstructive sleep apnea/hypopnea syndrome (OSAHS)
  • •Complaint of residual excessive sleepiness despite nasal continuous positive airway pressure (nCPAP) therapy being effective
  • •Current or prior diagnosis of major depressive disorder or dysthymic disorder
  • •Clinically stable with regard to depressed mood and has shown a treatment response to selective serotonin reuptake inhibitor (SSRI) therapy or serotonin and norepinephrine reuptake inhibitor (SNRI) therapy
  • •Patient has been on a stable monotherapy dose of an allowed SSRI or SNRI for at least 8 weeks at the time of screening
  • •Women of childbearing potential must use a medically accepted method of contraception.

排除标准

  • •Confirmed or suspected diagnosis of a currently active sleep disorder other than obstructive sleep apnea/hypopnea syndrome (OSAHS)
  • •Current episode of major depression that is considered to be treatment-resistant
  • •A primary diagnosis of: eating disorder, psychotic disorder, delirium, dementia, substance-related disorders, or moderate to severe hypochondriasis
  • •Patient has a history of bipolar disorder, psychotic depression, schizophrenia, schizoaffective disorder, any other psychotic disorder, or other clinically significant uncontrolled psychiatric condition.
  • •Patient has a history of homicidal ideation or significant aggression
  • •Patient has a diagnosis of severe antisocial or borderline personality disorder
  • •Has a history of significant suicidal ideation, or has current active suicidal ideation, or is considered at imminent risk of self harm.
  • •Patient has a history consistent with fibromyalgia or chronic fatigue syndrome
  • •A high consumption of caffeinated products, approximately equivalent to 5 or more cups of coffee per day
  • •Patient history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction
  • •Has a past or present seizure disorder
  • •Patient has a history of alcohol, narcotic, or any other substance abuse or dependence (with the exception of nicotine)
  • •Psychotherapeutic intervention for the patient was initiated within 8 weeks of the screening visit.
  • •Patient has known human immunodeficiency virus (HIV)
  • •Patient has any clinically significant uncontrolled medical condition (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition (treated or untreated)
  • •Patient is a pregnant or lactating woman
  • •Patient has previously received armodafinil; or, patient has used modafinil or any investigational product within 28 days of the baseline visit.

研究组 & 干预措施

1

Active Comparator

armodafinil 200 mg/day

干预措施: armodafinil (Drug)

2

Placebo Comparator

Placebo

干预措施: placebo (Drug)

结局指标

主要结局

Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline)

时间窗: Baseline and 12 weeks (or last observation after baseline)

MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes.

Clinical Global Impression of Change (CGI-C) at Endpoint (12-weeks or Last Observation After Baseline)

时间窗: 12 weeks (or last observation after baseline)

The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least "minimally improved" in CGI-C ratings (as related to sleepiness) were assessed.

次要结局

  • Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)(Baseline and 12 weeks (or last observation after baseline))
  • Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks(baseline and 4 weeks)
  • Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks(Baseline and 8 weeks following start of study drug administration)
  • Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks(baseline and 12 weeks (or last observation after baseline))
  • Clinical Global Impression of Change (CGI-C) at 4 Weeks(4 weeks after beginning study drug treatment)
  • Clinical Global Impression of Change (CGI-C) at 8 Weeks(8 weeks after beginning study drug treatment)
  • Clinical Global Impression of Change (CGI-C) at 12 Weeks(12 weeks after beginning treatment)
  • Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale(4 weeks after start of treatment)
  • Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale(8 weeks after start of study drug treatment)
  • Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale(12 weeks after starting study drug treatment)
  • Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks(Baseline and 2 weeks following start of study drug administration)
  • Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks(Baseline and 4 weeks after start of study drug administration)
  • Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks(Baseline and 8 weeks after start of study drug administration)
  • Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks(12 weeks (or last observation after baseline))
  • Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks(2 weeks)
  • Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks(4 weeks)
  • Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks(8 weeks)
  • Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks(12 weeks)
  • Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score(Baseline and 12 weeks following start of study drug administration or last recorded observation)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks(Baseline and 2 weeks after start of study drug administration)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks(Baseline and 4 weeks after start of study drug administration)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks(Baseline and 8 weeks after start of study drug administration)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks(Baseline and 12 weeks after start of study drug administration)
  • Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)(Baseline and 12 weeks or last observation after baseline)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks(Baseline and 2 weeks after start of study drug administration)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks(Baseline and 4 weeks after start of study drug administration)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks(Baseline and 8 weeks after start of study drug administration)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks(12 weeks)
  • Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)(12 weeks after start of study drug administration (or last observation after baseline))
  • Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks(2 weeks after start of study drug administration)
  • Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks(4 weeks after start of study drug administration)
  • Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks(8 weeks after start of study drug administration)
  • Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks(12 weeks after start of study drug administration)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)(Baseline and at endpoint (12 weeks or last observation after baseline))
  • Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks(Baseline and 2 weeks after start of study drug administration)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks(Baseline and 4 weeks after start of study drug administration)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks(Baseline and 8 weeks after start of study drug administration)
  • Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)(Baseline and 12 weeks after start of study drug administration)
  • Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)(Baseline and endpoint (12 weeks after start of study drug or last observation after baseline))
  • Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks(baseline and 2 weeks following start of study drug administration)
  • Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks(baseline and 4 weeks following start of study drug administration)
  • Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks(baseline and 8 weeks following start of study drug administration)
  • Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks(baseline and 12 weeks following the start of study drug administration)
  • Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)(Endpoint (week 12 or last observation after baseline))
  • Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks(2 weeks following start of study drug administration)
  • Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4(4 weeks following start of study drug administration)
  • Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8(8 weeks following start of study drug administration)
  • Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12(12 weeks following the start of study drug administration)
  • Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)(Baseline and Endpoint (12 weeks or last observation after baseline))
  • Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks(baseline and 2 weeks)
  • Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks(baseline and 4 weeks following start of study drug administration)
  • Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks(baseline and 8 weeks following start of study drug administration)
  • Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks(baseline and 12 weeks following start of study drug administration)
  • Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)(Baseline and Endpoint (12 weeks or last observation after baseline))
  • Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks(Baseline and 2 weeks)
  • Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks(Baseline and 4 weeks following start of study drug administration)
  • Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks(baseline and 8 weeks following start of study drug administration)
  • Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks(Baseline and 12 weeks following start of study drug administration)

研究者

发起方
Cephalon
申办方类型
Industry
责任方
Sponsor

研究点 (57)

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