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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00518986
First received: August 17, 2007
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Sleep Disorders
Obstructive Sleep Apnea
Major Depressive Disorder
Dysthymic Disorder
Drug: armodafinil
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 Depressive Disorder or Dysthymic Disorder

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. The results for the number of participants who responded to each item on the full scale at 4 weeks are presented.

  • Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale [ Time Frame: 8 weeks after start of study drug treatment ] [ Designated as safety issue: No ]
    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. The results for the number of participants who responded to each item on the full scale at 8 weeks are presented.

  • Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale [ Time Frame: 12 weeks after starting study drug treatment ] [ Designated as safety issue: No ]
    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. The results for the number of participants who responded to each item on the full scale at 12 weeks are presented.

  • Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks [ Time Frame: Baseline and 2 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    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 two weeks are summarized.

  • Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks [ Time Frame: Baseline and 4 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    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 4 weeks are summarized.

  • Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks [ Time Frame: Baseline and 8 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    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 8 weeks are summarized.

  • Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks [ Time Frame: 12 weeks (or last observation after baseline) ] [ Designated as safety issue: No ]
    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 12 weeks are summarized.

  • Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 2 weeks are presented.

  • Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 4 weeks are presented.

  • Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 8 weeks are presented.

  • Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 number of responders who had a total ESS score < 10 and the number of non-responders with a total score >= 10 at 12 weeks are presented.

  • Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score [ Time Frame: Baseline and 12 weeks following start of study drug administration or last recorded observation ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks or last observation after baseline.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks [ Time Frame: Baseline and 2 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 2 weeks.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks [ Time Frame: Baseline and 4 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 4 weeks.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks [ Time Frame: Baseline and 8 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 8 weeks.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks [ Time Frame: Baseline and 12 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The total score is calculated by taking the sum of all 9 rating scales for a minimum score of 0 and a maximum score of 90. This assessment examines the difference in total BFI score from Baseline to 12 weeks.

  • Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) [ Time Frame: Baseline and 12 weeks or last observation after baseline ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with >= 7 indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12 (or last observation after baseline).

  • Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks [ Time Frame: Baseline and 2 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 2.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks [ Time Frame: Baseline and 4 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 4.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks [ Time Frame: Baseline and 8 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 8.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) is a subjective-completed tool for the assessment of the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. This measure compares the change in score from baseline to Week 12.

  • Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline) [ Time Frame: 12 weeks after start of study drug administration (or last observation after baseline) ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12 or last observation after baseline.

  • Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks [ Time Frame: 2 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 2.

  • Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks [ Time Frame: 4 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 4.

  • Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks [ Time Frame: 8 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 8.

  • Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks [ Time Frame: 12 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The worst daily fatigue score reports the outcome of a single item on the BFI that rates the worst fatigue experienced over the day on a scale from 0 to 10 with 0 being no fatigue and 10 being most severe. Subjects were considered responders if the final Worst Fatigue Score was < 7 at Week 12.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline) [ Time Frame: Baseline and at endpoint (12 weeks or last observation after baseline) ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks [ Time Frame: Baseline and 2 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks [ Time Frame: Baseline and 4 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks [ Time Frame: Baseline and 8 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.

  • Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline) [ Time Frame: Baseline and 12 weeks after start of study drug administration ] [ Designated as safety issue: No ]
    The Brief Fatigue Inventory (BFI) assesses the impact of fatigue on daily functioning. Simple numeric rating scales from 0 to 10 are used. The higher scores are associated with more severe fatigue, with any score >= 7 considered to be indicative of severe fatigue. The Interference Score consists of 6 questions that ask subjects to rate on a 0 to 10 scale how during the past 24 hours fatigue has interfered with their general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. The scores are averaged (0-10) for the Interference Score.

  • Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline) [ Time Frame: Baseline and endpoint (12 weeks after start of study drug or last observation after baseline) ] [ Designated as safety issue: No ]
    The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum of 2 maximum of 120) was calculated from the responses. The change in total score from baseline to Endpoint (12 weeks or last observation after baseline) is presented here.

  • Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks [ Time Frame: baseline and 2 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 2 weeks is presented here.

  • Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks [ Time Frame: baseline and 4 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 4 weeks is presented here.

  • Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks [ Time Frame: baseline and 8 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 8 weeks is presented here.

  • Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks [ Time Frame: baseline and 12 weeks following the start of study drug administration ] [ Designated as safety issue: No ]
    The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. The change in total score from baseline to 12 weeks is presented here.

  • Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline) [ Time Frame: Endpoint (week 12 or last observation after baseline) ] [ Designated as safety issue: No ]
    The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at Endpoint (12 weeks or last observation after baseline) is presented.

  • Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks [ Time Frame: 2 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum=120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 2 weeks is presented here.

  • Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 4 [ Time Frame: 4 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum=2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 4 weeks is presented here.

  • Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 8 [ Time Frame: 8 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score was calculated from the responses (minimum = 2 maximum = 120). A responder analysis defining responders as patients with a total score > 17.9 at 8 weeks is presented here.

  • Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12 [ Time Frame: 12 weeks following the start of study drug administration ] [ Designated as safety issue: No ]
    The FOSQ is a self-administered questionnaire that assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors. The questionnaire contains 30 questions each rated from 1 to 4 (1 indicating extreme difficulty 4 indicating no difficulty, or 0 indicating not applicable). A total score (minimum = 2 maximum = 120) was calculated from the responses. A responder analysis defining responders as patients with a total score > 17.9 at 12 weeks is presented here.

  • Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline) [ Time Frame: Baseline and Endpoint (12 weeks or last observation after baseline) ] [ Designated as safety issue: No ]
    The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning:confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. Responses range from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 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 [ Time Frame: baseline and 2 weeks ] [ Designated as safety issue: No ]
    The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 2 weeks.

  • Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks [ Time Frame: baseline and 4 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 4 weeks.

  • Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks [ Time Frame: baseline and 8 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 8 weeks.

  • Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks [ Time Frame: baseline and 12 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    The MOS-CF6 assesses self-reported cognitive function. Items were selected to cover 6 relevant aspects of cognitive functioning as follows: confusion, concentration/thinking, attention, memory, reasoning, problem-solving, and processing speed. The MOS-CF6 responses includes 6 choices, ranging from "none of the time" to "all of the time". The MOS-CF6 is scored by summing responses across the 6 items and converting the total to a 0 - 100 point scale, with the higher score indicating better cognitive functioning. Data is presented showing the change in score from baseline to 12 weeks.

  • Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline) [ Time Frame: Baseline and Endpoint (12 weeks or last observation after baseline) ] [ Designated as safety issue: No ]
    The Excessive Sleepiness Symptom Rating Form was used to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(tiredness, fatigue, sleepiness, lack of energy, trouble paying attention, forgetfulness, trouble staying organized) on an 11-point Likert scale (0 = no problem at all to 10 = as bad as you can imagine). ES Symptom Rating Form was designed to follow the response to treatment measuring severity of each of these 7 symptoms using the same 11-point scale. Change from Baseline to Endpoint (12 weeks or last baseline observation) is presented only for the symptom of "Sleepiness".

  • Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 2 Weeks is presented only for the symptom of "Sleepiness".

  • Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks [ Time Frame: Baseline and 4 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 4 Weeks is presented only for the symptom of "Sleepiness".

  • Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks [ Time Frame: baseline and 8 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 8 Weeks is presented only for the symptom of "Sleepiness".

  • Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks [ Time Frame: Baseline and 12 weeks following start of study drug administration ] [ Designated as safety issue: No ]
    Cephalon created the Excessive Sleepiness Symptom Rating Form to assess symptoms of excessive sleepiness. Patients rate 7 symptoms(Tiredness, Fatigue, Sleepiness, Lack of energy, Trouble paying attention, Forgetfulness, Trouble staying organized) each on an 11-point Likert scale(0="no problem at all" 10="as bad as you can imagine"). ES Symptom Rating Form was designed to follow the response to treatment (measuring severity) of each of these 7 symptoms using the same 11-point scale. Change from Baseline to 12 Weeks is presented only for the symptom of "Sleepiness".


Enrollment: 249
Study Start Date: October 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
armodafinil 200 mg/day
Drug: armodafinil
200 mg/day
Placebo Comparator: 2
Placebo
Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518986

  Show 62 Study Locations
Sponsors and Collaborators
Cephalon
  More Information

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00518986     History of Changes
Other Study ID Numbers: C10953/4024/ES/US
Study First Received: August 17, 2007
Results First Received: March 30, 2010
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Obstructive Sleep Apnea/Hypopnea Syndrome
Excessive Sleepiness

Additional relevant MeSH terms:
Apnea
Depressive Disorder
Depression
Dysthymic Disorder
Sleep Apnea Syndromes
Sleep Disorders
Parasomnias
Depressive Disorder, Major
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014