Clinical Trial: Efficacy and Safety of Armodafinil for Adults With Excessive Sleepiness Obstructive Sleep Apnea/Hypopnea and Depression

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Dep

Brief Summary: 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.

Detailed Summary:
Sponsor: Cephalon

Current Primary Outcome:

  • Change From Baseline on Maintenance of Wakefulness Test (MWT) to Endpoint (12 Weeks or Last Observation After Baseline) [ Time Frame: 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) [ Time Frame: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline) [ Time Frame: Baseline and 12 weeks (or last observation after baseline) ]
    For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized.
  • Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks [ Time Frame: baseline and 4 weeks ]
    MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 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 occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
  • Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks [ Time Frame: Baseline and 8 weeks following start of study drug administration ]
    MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 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 occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 8 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
  • Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks [ Time Frame: 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 four 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 occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 12 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes.
  • Clinical Global Impression of Change (CGI-C) at 4 Weeks [ Time Frame: 4 weeks after beginning study drug treatment ]
    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 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories 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) at 4 weeks were assessed.
  • Clinical Global Impression of Change (CGI-C) at 8 Weeks [ Time Frame: 8 weeks after beginning study drug treatment ]
    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 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories 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) at 8 weeks were assessed.
  • Clinical Global Impression of Change (CGI-C) at 12 Weeks [ Time Frame: 12 weeks after beginning treatment ]
    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 7 responses: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimal improvement in CGI-C ratings (as related to sleepiness) were assessed.
  • Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale [ Time Frame: 4 weeks after start of treatment ]
    The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Sever

    Original Secondary Outcome:

    Information By: Teva Pharmaceutical Industries

    Dates:
    Date Received: August 17, 2007
    Date Started: October 2007
    Date Completion:
    Last Updated: July 12, 2013
    Last Verified: July 2013