Page last updated: 2024-10-31

modafinil and Dysthymic Disorder

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)

Research

Studies (2)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's1 (50.00)29.6817
2010's1 (50.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Krystal, AD1
Harsh, JR1
Yang, R1
Yang, RR1
Rippon, GA1
Lankford, DA1
Ashton, AK1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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 4249 participants (Actual)Interventional2007-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 12 Weeks

"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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-2.2
Placebo-1.3

Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 2 Weeks

"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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.6
Placebo-1.2

Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 4 Weeks

"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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-2.1
Placebo-1.1

Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at 8 Weeks

"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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.8
Placebo-0.9

Change From Baseline in the Excessive Sleepiness (ES) Symptom Rating Form - Sleepiness Scores at Endpoint (12 Weeks or Last Observation After Baseline)

"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)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.8
Placebo-1.4

Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 12 Weeks (or Last Observation After Baseline)

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.1
Placebo-0.3

Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 2 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-0.6
Placebo0.0

Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 4 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.0
Placebo-0.6

Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at 8 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-0.9
Placebo-0.2

Change From Baseline on Brief Fatigue Inventory (BFI) Interference Score at Endpoint (12 Weeks or Last Observation After Baseline)

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)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-0.9
Placebo-0.3

Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 12 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-10.5
Placebo-3.3

Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 2 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-6.1
Placebo-0.9

Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 4 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-9.5
Placebo-5.8

Change From Baseline on Brief Fatigue Inventory (BFI) Total Score at 8 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-8.8
Placebo-3.0

Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 12 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.4
Placebo-0.6

Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 2 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.1
Placebo-0.2

Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 4 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.2
Placebo-0.8

Change From Baseline on Brief Fatigue Inventory (BFI) Worse Daily Fatigue Score at 8 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.2
Placebo-0.3

Change From Baseline on Epworth Sleepiness Scale (ESS) at 12 Weeks

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)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-6.8
Placebo-4.8

Change From Baseline on Epworth Sleepiness Scale (ESS) at 2 Weeks

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

InterventionUnit on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-4.8
Placebo-3.8

Change From Baseline on Epworth Sleepiness Scale (ESS) at 4 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-5.5
Placebo-4.2

Change From Baseline on Epworth Sleepiness Scale (ESS) at 8 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-6.0
Placebo-4.8

Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 12 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day2.6
Placebo1.6

Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day1.7
Placebo1.1

Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 4 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day2.2
Placebo1.4

Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 8 Weeks

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day2.2
Placebo1.4

Change From Baseline on Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (12 Weeks or Last Observation After Baseline)

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)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day2.3
Placebo1.5

Change From Baseline on Maintenance of Wakefulness Test (MWT) at 12 Weeks

MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 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)

InterventionMinutes (Least Squares Mean)
Armodafinil 200 mg/Day2.5
Placebo1.4

Change From Baseline on Maintenance of Wakefulness Test (MWT) at 4 Weeks

MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 4 weeks in mean sleep latency (measured in minutes)averaged from each of the four testing intervals was measured. The poorest outcome was 0 minutes the best was 30 minutes. (NCT00518986)
Timeframe: baseline and 4 weeks

InterventionMinutes (Least Squares Mean)
Armodafinil 200 mg/Day2.7
Placebo-0.1

Change From Baseline on Maintenance of Wakefulness Test (MWT) at 8 Weeks

MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of four 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occured. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to 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

InterventionMinutes (Least Squares Mean)
Armodafinil 200 mg/Day2.1
Placebo1.2

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

MWT measures ability of subject to remain awake. Subjects instructed to try and remain awake during series of 4 30-minute periods (0900, 1100, 1300, and 1500) reclining in dark room. Each period was terminated immediately after sleep onset or at end of 30 minutes if no sleep occurred. If subject fell asleep, they were awakened and not allowed to sleep for remainder of that 30 minute period. Change from Baseline to Endpoint (12 weeks or last observation after baseline) in mean sleep latency averaged from the 4 intervals was measured. Poorest outcome was 0 minutes the best was 30 minutes. (NCT00518986)
Timeframe: Baseline and 12 weeks (or last observation after baseline)

InterventionMinutes (Mean)
Armodafinil 200 mg/Day2.6
Placebo1.1

Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 12 Weeks

"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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day3.3
Placebo2.4

Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 2 Weeks

"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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day2.0
Placebo1.9

Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 4 Weeks

"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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day3.4
Placebo2.4

Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at 8 Weeks

"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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day3.3
Placebo2.1

Change From Baseline on Medical Outcomes Study 6 Item Cognitive Functioning (MOS-CF6) Scale at Endpoint (12 Weeks or Last Observation After Baseline)

"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)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day3.2
Placebo2.4

Change From Baseline on the Brief Fatigue Inventory (BFI) Worst Daily Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-1.3
Placebo-0.7

Change From Baseline on the Epworth Sleepiness Scale (ESS) at Endpoint (12 Weeks or Last Measurement After Baseline)

For this key secondary outcome the ESS score is based on responses to questions (self administered) that assessed the propensity of the subject to fall asleep in 8 everyday situations (sitting and reading, talking to someone, being stopped in traffic, etc.) Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness. The change in ESS total score from baseline to Endpoint (12 weeks or last observation after baseline) are summarized. (NCT00518986)
Timeframe: Baseline and 12 weeks (or last observation after baseline)

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-6.5
Placebo-4.6

Change From Baseline to Endpoint (Week 12 or Last Observation After Baseline) in the Brief Fatigue Inventory (BFI) Total Score

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

InterventionUnits on a scale (Least Squares Mean)
Armodafinil 200 mg/Day-8.9
Placebo-3.8

Clinical Global Impression of Change (CGI C) at 4 Weeks - Full Scale

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

,
InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Armodafinil 200 mg/Day15342632310
Placebo11213237520

Clinical Global Impression of Change (CGI-C) at 12 Weeks

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

,
InterventionParticipants (Number)
At least minimal improvementNo improvement
Armodafinil 200 mg/Day6927
Placebo5342

Clinical Global Impression of Change (CGI-C) at 12 Weeks - Full Scale

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

,
InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Armodafinil 200 mg/Day27202222410
Placebo11222034710

Clinical Global Impression of Change (CGI-C) at 4 Weeks

"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

,
InterventionParticipants (Number)
At least minimal improvementNo improvement
Armodafinil 200 mg/Day7536
Placebo6444

Clinical Global Impression of Change (CGI-C) at 8 Weeks

"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

,
InterventionParticipants (Number)
At least minimal improvementNo improvement
Armodafinil 200 mg/Day7628
Placebo5246

Clinical Global Impression of Change (CGI-C) at 8 Weeks - Full Scale

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

,
InterventionParticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Armodafinil 200 mg/Day16392126110
Placebo11192237720

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

"The CGI-C is a clinician's rating of disease severity compared with baseline as assessed by Clinical Global Impression of Severity (CGI-S). CGI-C rates improvement by 7 categories: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. CGI-S measured 7 categories of illness as well: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among most extremely ill. Proportion of responders who had at least minimally improved in CGI-C ratings (as related to sleepiness) were assessed." (NCT00518986)
Timeframe: 12 weeks (or last observation after baseline)

,
InterventionParticipants (Number)
At least minimal improvementNo improvement
Armodafinil 200 mg/Day7835
Placebo5953

Number of Responders According to Brief Fatigue Inventory (BFI) Worst Fatigue Score at Endpoint (12 Weeks or Last Observation After Baseline)

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)

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6349
Placebo5655

Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 12 Weeks

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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day5541
Placebo4847

Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 2 Weeks

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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6248
Placebo4365

Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 4 Weeks

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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6249
Placebo5751

Number of Responders According to the Brief Fatigue Inventory (BFI) Worst Fatigue Score at 8 Weeks

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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6341
Placebo4256

Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 12 Weeks

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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6531
Placebo4748

Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 2 Weeks

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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day5453
Placebo4064

Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 4 Weeks

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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day5952
Placebo4563

Number of Responders According to the Epworth Sleepiness Scale (ESS) Total Score at 8 Weeks

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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day6439
Placebo4751

Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 12

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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day4351
Placebo2866

Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 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. 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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day4560
Placebo2479

Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) at Week 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 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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day3665
Placebo2077

Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at 2 Weeks

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

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day3075
Placebo1984

Number of Responders According to the Functional Outcomes of Sleep Questionnaire (FOSQ) Total Score at Endpoint (Week 12 or Last Observation After Baseline)

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)

,
InterventionParticipants (Number)
RespondersNon-responders
Armodafinil 200 mg/Day4961
Placebo3078

Trials

1 trial available for modafinil and Dysthymic Disorder

ArticleYear
A double-blind, placebo-controlled study of armodafinil for excessive sleepiness in patients with treated obstructive sleep apnea and comorbid depression.
    The Journal of clinical psychiatry, 2010, Volume: 71, Issue:1

    Topics: Antidepressive Agents; Benzhydryl Compounds; Central Nervous System Stimulants; Continuous Positive

2010

Other Studies

1 other study available for modafinil and Dysthymic Disorder

ArticleYear
Modafinil augmentation of phenelzine for residual fatigue in dysthymia.
    The American journal of psychiatry, 2004, Volume: 161, Issue:9

    Topics: Benzhydryl Compounds; Central Nervous System Stimulants; Comorbidity; Disorders of Excessive Somnole

2004