modafinil has been researched along with Dysthymic Disorder in 2 studies
Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.
modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.
2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group.
Dysthymic Disorder: Chronically depressed mood that occurs for most of the day more days than not for at least 2 years. The required minimum duration in children to make this diagnosis is 1 year. During periods of depressed mood, at least 2 of the following additional symptoms are present: poor appetite or overeating, insomnia or hypersomnia, low energy or fatigue, low self-esteem, poor concentration or difficulty making decisions, and feelings of hopelessness. (DSM-IV)
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 1 (50.00) | 29.6817 |
2010's | 1 (50.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Krystal, AD | 1 |
Harsh, JR | 1 |
Yang, R | 1 |
Yang, RR | 1 |
Rippon, GA | 1 |
Lankford, DA | 1 |
Ashton, AK | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
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[NCT00518986] | Phase 4 | 249 participants (Actual) | Interventional | 2007-10-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"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." (NCT00518986)
Timeframe: Baseline and 12 weeks following start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -2.2 |
Placebo | -1.3 |
"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." (NCT00518986)
Timeframe: Baseline and 2 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -1.6 |
Placebo | -1.2 |
"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." (NCT00518986)
Timeframe: Baseline and 4 weeks following start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -2.1 |
Placebo | -1.1 |
"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." (NCT00518986)
Timeframe: baseline and 8 weeks following start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -1.8 |
Placebo | -0.9 |
"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." (NCT00518986)
Timeframe: Baseline and Endpoint (12 weeks or last observation after baseline)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -1.8 |
Placebo | -1.4 |
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. (NCT00518986)
Timeframe: Baseline and 12 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -1.1 |
Placebo | -0.3 |
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. (NCT00518986)
Timeframe: Baseline and 2 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -0.6 |
Placebo | 0.0 |
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. (NCT00518986)
Timeframe: Baseline and 4 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -1.0 |
Placebo | -0.6 |
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. (NCT00518986)
Timeframe: Baseline and 8 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -0.9 |
Placebo | -0.2 |
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. (NCT00518986)
Timeframe: Baseline and at endpoint (12 weeks or last observation after baseline)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -0.9 |
Placebo | -0.3 |
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. (NCT00518986)
Timeframe: Baseline and 12 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -10.5 |
Placebo | -3.3 |
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. (NCT00518986)
Timeframe: Baseline and 2 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -6.1 |
Placebo | -0.9 |
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. (NCT00518986)
Timeframe: Baseline and 4 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -9.5 |
Placebo | -5.8 |
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. (NCT00518986)
Timeframe: Baseline and 8 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -8.8 |
Placebo | -3.0 |
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. (NCT00518986)
Timeframe: 12 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -1.4 |
Placebo | -0.6 |
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. (NCT00518986)
Timeframe: Baseline and 2 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -1.1 |
Placebo | -0.2 |
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. (NCT00518986)
Timeframe: Baseline and 4 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -1.2 |
Placebo | -0.8 |
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. (NCT00518986)
Timeframe: Baseline and 8 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -1.2 |
Placebo | -0.3 |
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. (NCT00518986)
Timeframe: 12 weeks (or last observation after baseline)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -6.8 |
Placebo | -4.8 |
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. (NCT00518986)
Timeframe: Baseline and 2 weeks following start of study drug administration
Intervention | Unit on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -4.8 |
Placebo | -3.8 |
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. (NCT00518986)
Timeframe: Baseline and 4 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -5.5 |
Placebo | -4.2 |
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. (NCT00518986)
Timeframe: Baseline and 8 weeks after start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -6.0 |
Placebo | -4.8 |
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. (NCT00518986)
Timeframe: baseline and 12 weeks following the start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 2.6 |
Placebo | 1.6 |
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. (NCT00518986)
Timeframe: baseline and 2 weeks following start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 1.7 |
Placebo | 1.1 |
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. (NCT00518986)
Timeframe: baseline and 4 weeks following start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 2.2 |
Placebo | 1.4 |
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. (NCT00518986)
Timeframe: baseline and 8 weeks following start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 2.2 |
Placebo | 1.4 |
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. (NCT00518986)
Timeframe: Baseline and endpoint (12 weeks after start of study drug or last observation after baseline)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 2.3 |
Placebo | 1.5 |
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. (NCT00518986)
Timeframe: baseline and 12 weeks (or last observation after baseline)
Intervention | Minutes (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 2.5 |
Placebo | 1.4 |
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. (NCT00518986)
Timeframe: baseline and 4 weeks
Intervention | Minutes (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 2.7 |
Placebo | -0.1 |
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. (NCT00518986)
Timeframe: Baseline and 8 weeks following start of study drug administration
Intervention | Minutes (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 2.1 |
Placebo | 1.2 |
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. (NCT00518986)
Timeframe: Baseline and 12 weeks (or last observation after baseline)
Intervention | Minutes (Mean) |
---|---|
Armodafinil 200 mg/Day | 2.6 |
Placebo | 1.1 |
"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." (NCT00518986)
Timeframe: baseline and 12 weeks following start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 3.3 |
Placebo | 2.4 |
"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." (NCT00518986)
Timeframe: baseline and 2 weeks
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 2.0 |
Placebo | 1.9 |
"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." (NCT00518986)
Timeframe: baseline and 4 weeks following start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 3.4 |
Placebo | 2.4 |
"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." (NCT00518986)
Timeframe: baseline and 8 weeks following start of study drug administration
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 3.3 |
Placebo | 2.1 |
"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)." (NCT00518986)
Timeframe: Baseline and Endpoint (12 weeks or last observation after baseline)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | 3.2 |
Placebo | 2.4 |
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). (NCT00518986)
Timeframe: Baseline and 12 weeks or last observation after baseline
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -1.3 |
Placebo | -0.7 |
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. (NCT00518986)
Timeframe: Baseline and 12 weeks (or last observation after baseline)
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -6.5 |
Placebo | -4.6 |
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. (NCT00518986)
Timeframe: Baseline and 12 weeks following start of study drug administration or last recorded observation
Intervention | Units on a scale (Least Squares Mean) |
---|---|
Armodafinil 200 mg/Day | -8.9 |
Placebo | -3.8 |
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. (NCT00518986)
Timeframe: 4 weeks after start of treatment
Intervention | Participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
Armodafinil 200 mg/Day | 15 | 34 | 26 | 32 | 3 | 1 | 0 |
Placebo | 11 | 21 | 32 | 37 | 5 | 2 | 0 |
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. (NCT00518986)
Timeframe: 12 weeks after beginning treatment
Intervention | Participants (Number) | |
---|---|---|
At least minimal improvement | No improvement | |
Armodafinil 200 mg/Day | 69 | 27 |
Placebo | 53 | 42 |
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. (NCT00518986)
Timeframe: 12 weeks after starting study drug treatment
Intervention | Participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
Armodafinil 200 mg/Day | 27 | 20 | 22 | 22 | 4 | 1 | 0 |
Placebo | 11 | 22 | 20 | 34 | 7 | 1 | 0 |
"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." (NCT00518986)
Timeframe: 4 weeks after beginning study drug treatment
Intervention | Participants (Number) | |
---|---|---|
At least minimal improvement | No improvement | |
Armodafinil 200 mg/Day | 75 | 36 |
Placebo | 64 | 44 |
"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." (NCT00518986)
Timeframe: 8 weeks after beginning study drug treatment
Intervention | Participants (Number) | |
---|---|---|
At least minimal improvement | No improvement | |
Armodafinil 200 mg/Day | 76 | 28 |
Placebo | 52 | 46 |
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. (NCT00518986)
Timeframe: 8 weeks after start of study drug treatment
Intervention | Participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
Armodafinil 200 mg/Day | 16 | 39 | 21 | 26 | 1 | 1 | 0 |
Placebo | 11 | 19 | 22 | 37 | 7 | 2 | 0 |
"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." (NCT00518986)
Timeframe: 12 weeks (or last observation after baseline)
Intervention | Participants (Number) | |
---|---|---|
At least minimal improvement | No improvement | |
Armodafinil 200 mg/Day | 78 | 35 |
Placebo | 59 | 53 |
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. (NCT00518986)
Timeframe: 12 weeks after start of study drug administration (or last observation after baseline)
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 63 | 49 |
Placebo | 56 | 55 |
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. (NCT00518986)
Timeframe: 12 weeks after start of study drug administration
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 55 | 41 |
Placebo | 48 | 47 |
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. (NCT00518986)
Timeframe: 2 weeks after start of study drug administration
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 62 | 48 |
Placebo | 43 | 65 |
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. (NCT00518986)
Timeframe: 4 weeks after start of study drug administration
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 62 | 49 |
Placebo | 57 | 51 |
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. (NCT00518986)
Timeframe: 8 weeks after start of study drug administration
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 63 | 41 |
Placebo | 42 | 56 |
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. (NCT00518986)
Timeframe: 12 weeks
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 65 | 31 |
Placebo | 47 | 48 |
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. (NCT00518986)
Timeframe: 2 weeks
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 54 | 53 |
Placebo | 40 | 64 |
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. (NCT00518986)
Timeframe: 4 weeks
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 59 | 52 |
Placebo | 45 | 63 |
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. (NCT00518986)
Timeframe: 8 weeks
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 64 | 39 |
Placebo | 47 | 51 |
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. (NCT00518986)
Timeframe: 12 weeks following the start of study drug administration
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 43 | 51 |
Placebo | 28 | 66 |
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. (NCT00518986)
Timeframe: 4 weeks following start of study drug administration
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 45 | 60 |
Placebo | 24 | 79 |
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. (NCT00518986)
Timeframe: 8 weeks following start of study drug administration
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 36 | 65 |
Placebo | 20 | 77 |
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. (NCT00518986)
Timeframe: 2 weeks following start of study drug administration
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 30 | 75 |
Placebo | 19 | 84 |
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. (NCT00518986)
Timeframe: Endpoint (week 12 or last observation after baseline)
Intervention | Participants (Number) | |
---|---|---|
Responders | Non-responders | |
Armodafinil 200 mg/Day | 49 | 61 |
Placebo | 30 | 78 |
1 trial available for modafinil and Dysthymic Disorder
Article | Year |
---|---|
A double-blind, placebo-controlled study of armodafinil for excessive sleepiness in patients with treated obstructive sleep apnea and comorbid depression.
Topics: Antidepressive Agents; Benzhydryl Compounds; Central Nervous System Stimulants; Continuous Positive | 2010 |
1 other study available for modafinil and Dysthymic Disorder
Article | Year |
---|---|
Modafinil augmentation of phenelzine for residual fatigue in dysthymia.
Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Comorbidity; Disorders of Excessive Somnole | 2004 |