modafinil and Depression, Involutional

modafinil has been researched along with Depression, Involutional in 46 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.

Depression, Involutional: Form of depression in those MIDDLE AGE with feelings of ANXIETY.

Research

Studies (46)

Authors

Clinical Trials (7)

Trial Overview

Trial Outcomes

Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score

HAM-A measures the severity of anxiety symptoms. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Negative change from baseline scores indicate a decrease in severity of anxiety. (NCT01072929)
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score

The ISI is a participant-rated, 7-item questionnaire designed to assess the severity of the participant's insomnia. Each item is ranked 0 (none) through 4 (very severe) and has a descriptor associated with each severity level. Total range is 0 (no insomnia) to 28 (very severe insomnia). Responses to each item are added to obtain a total score to determine the severity of insomnia. Negative change from baseline scores indicate a decrease in severity of insomnia. (NCT01072929)
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score

The YMRS is a clinician-rated, 11-item checklist used to measure the severity of manic episodes. Information for assigning scores is gained from the participant's subjective reported symptoms over the previous 48 hours and from clinical observation during the interview. Seven items are ranked 0 through 4 and have descriptors associated with each severity level. Four items (irritability, speech, content, and disruptive-aggressive behavior) are scored 0 through 8 and have descriptors for every second increment. The total scale is 0-60. A score of ≤12 indicates remission of manic symptoms, and higher scores indicate greater severity of mania. Negative change from baseline scores indicate a decrease in severity of mania. (NCT01072929)
Timeframe: Day 0 (baseline), last postbaseline observation (up to 8 weeks)

Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression." (NCT01072929)
Timeframe: Day 0 (baseline), Week 8

Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression

The CGI-S is an observer-rated scale that measures illness severity on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). Negative change from baseline values indicate improvement in the severity of depression. (NCT01072929)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)

The QIDS-C16 was derived from specified items in the IDS-C30, clinician-rated scale to assess the severity of a participant's depressive symptoms. Total scores range from 0-27, with a score of 0 indicating no depression and a score of 27 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression. (NCT01072929)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

"The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression." (NCT01072929)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale

The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. Ratings of 1 - 10 mean the participant is in persistent danger of severely hurting self or others (e.g., recurrent violence) or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death. Ratings of 91 - 100 indicate no symptoms, and the participant exhibits superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many positive qualities. Positive change from baseline values indicate improvement in functioning. (NCT01072929)
Timeframe: Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Aborted Attempt question records whether the participant began to take steps toward making a suicide attempt but stops themselves before starting the potentially self-injurious act since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question

The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation. The Suicidal Behavior - Actual Attempt question records whether the participant committed a potentially self-injurious act with at least some wish to die since the last visit. (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Completed Suicide question records whether the participant intentionally causing his/her's own death since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Interrupted Attempt question records whether the participant was interrupted by an outside circumstance from starting the potentially self-injurious act with at least some wish to die since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Non-Suicidal Self-Injurious Behavior question records whether the participant committed a potentially self-injurious act that was not associated with a wish to die since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Preparatory Acts or Behavior question records whether the participant exhibited acts or preparations towards imminently making a suicide attempt since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Behavior - Suicidal Behavior question records whether in the clinician's opinion, the participant exhibited suicidal behavior since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act question records whether the participant endorses thoughts of suicide and has thought of at least one method but has no specific plan of action since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Non-Specific Active Suicidal Thoughts question records whether the participant shares general non-specific thoughts of wanting to end one's life/commit suicide since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Some Intent to Act Without a Specific Plan question records whether the participant has active suicidal thoughts of killing oneself and reports having some intent to act on such thoughts since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Specific Plan and Intent question records whether the participant has active suicidal thoughts of killing oneself with details of plan fully or partially worked out and the participant has some intent to carry out the plan since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question

"The C-SSRS is a clinician-rated scale that assesses suicidality from ideation to behaviors and monitors the potential emergence of suicidality in clinical studies. The C-SSRS-B (baseline) was performed at screening and the C-SSRS-SLV ('Since Last Visit') was performed at baseline and weeks 1, 2, 4, 6, 7, and 8 or last postbaseline observation.~The Suicidal Ideation - Wish to Be Dead question records whether the participant endorses thoughts about a wish to dead or not alive anymore, or a wish to fall asleep and not wake up since the last visit." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, 8, and Endpoint (up to 8 weeks)

Participants With Treatment-Emergent Adverse Events (TEAE)

"AEs were graded by the investigator for severity on a three-point scale: mild, moderate and severe. Causality is graded as either related or not related. A serious adverse event (SAE) is an AE resulting in death, a life-threatening adverse event, hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event that may require medical intervention to prevent any of the previous results.~Protocol-defined adverse events requiring expedited reporting included skin rash, hypersensitivity reaction, emergent suicidal ideation or suicide attempt, and psychosis." (NCT01072929)
Timeframe: Day 1 to Week 9

Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

"A participant in remission was defined as a participant with an IDS-C30 total score of 11 or less.~The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression." (NCT01072929)
Timeframe: Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score

"A responder is a participant with a ≥50% decrease or greater from baseline in the total score of the IDS-C30. The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits.~Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression." (NCT01072929)
Timeframe: Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks)

1 Week Delayed Recall Logical Memory

Higher scores reflect greater recall of Wechsler Memory Scale (WMS) Story B content assessed one week after last rehearsal. Possible scores range from 0 to 25. (NCT02376257)
Timeframe: Week 2 and Week 3

1 Week Delayed Recall of Emotional Story Items

1 Week Delayed Recall of a Threat-Related Story. Scores can range from 0 to 74, with higher scores reflect greater memory for story items. (NCT02376257)
Timeframe: Week 2 and Week 3

Digits Backward

The examiner reads a list of digits and asks that each digit be read backwards. The score is the total number of trials completed correctly; scores range from 0 to 16. Higher scores indicate better performance. (NCT02376257)
Timeframe: Baseline, Week 1, Week 2, Week 3

Immediate Memory Measured by the Hopkins Verbal Learning Task

The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The patient's free recall of the list is recorded. The same procedure is repeated for two more trials. The total recall score for the third trial was used as the recorded score and ranged from a minimum of zero to a maximum of 12 correct answers. (NCT02376257)
Timeframe: Baseline, Week 1, Week 2, Week 3

Immediate Recall of Emotional Story Items

Immediate recall score of items from the Emotional Story presentation. Scores can range from 0 to 74, with higher scores reflect greater memory for story items. (NCT02376257)
Timeframe: Week 1, Week 2, Week 3

Logical Memory Immediate Recall

Immediate Story Recall from the Wechsler Memory Scale Story B. Higher scores reflect greater recall of the story material from the previous week. Possible scores range from 0 to 25. (NCT02376257)
Timeframe: Week 1, Week 2, Week 3

Recall of Cognitive Therapy Content

A modified Cognitive Therapy Awareness Scale (CTAS) was used to assess delayed memory for cognitive therapy content from the computerized CBT. Higher scores indicate better memory for CBT skills. Scores range from 0 to 40. (NCT02376257)
Timeframe: Week 2 and Week 3

Skills of Cognitive Therapy

This measure assesses the self-reported use of skills from cognitive therapy. Scores can range from 8 to 40, and higher scores indicate greater use. (NCT02376257)
Timeframe: Week 2 and Week 3

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

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

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

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

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)

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

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

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

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

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)

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

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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)

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)

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

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

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)

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

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

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

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

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)

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

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)

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

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

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

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

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

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

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

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)

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)

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

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

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

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

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

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

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

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

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

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

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

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

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)

Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score

The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 4 Weeks (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score

The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety and 25-30 moderate to severe. The data presented here summarizes the change in HAM-A score from Baseline to 8 Weeks (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score

The HAM-A is a clinician-rated 14 item scale that provides an overall measure of global anxiety, including psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0 - 56, where less than 17 indicates mild anxiety, 18 - 24 mild to moderate anxiety, 25-30 moderate to severe, >30 very severe. The data presented here summarizes the change in HAM-A score from Baseline to Endpoint (8 weeks or last observation after baseline). (NCT00481195)
Timeframe: baseline and 8 weeks (or last observation after baseline)

Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the change in MADRS from Baseline to Endpoint. (NCT00481195)
Timeframe: Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline)

Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to endpoint (8 weeks or last observation after baseline). (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Endpoint (Week 8 or last observation after baseline). (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to Endpoint in the score of Item 4 assessing hypersomnia. (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to Endpoint in the combined score of these three items assessing insomnia. (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 1 (NCT00481195)
Timeframe: Baseline and 1 week following the start of study drug administration

Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 2 (NCT00481195)
Timeframe: Baseline and 2 weeks following the start of study drug administration

Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 3. (NCT00481195)
Timeframe: Baseline and 3 weeks following the start of study drug administration

Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 4. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 4 weeks. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 4. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 4 in the score of Item 4 assessing hypersomnia. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 4 in the combined score of these three items assessing insomnia. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 6. (NCT00481195)
Timeframe: Baseline and 6 weeks following the start of study drug administration

Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale to evaluate the overall severity of a patient's depressive symptoms, that is completed by the physician. The rating scale makes use of both observational clues as to the subject's level of depression (eg. apparent sadness) and verbal indicators of depression expressed by the patient. Each of the 10 items is graded on a 6-point scale with anchors at 2 point intervals. Total scores range from 0 to 60, with the higher number indicating more severe symptoms of depression. Here we present data summarizing the difference in MADRS score from Baseline to Week 8. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

The Q-LES-Q-SF is an instrument designed to measure general activities of daily living. It is a patient-rated quality of life questionnaire and consists of 16 items, but only the first 14 are included in the total score. Each item is rated by the patient on a scale from 1 - 5 (1=very poor, 2=poor, 3=fair, 4=good, and 5=very good). The minimum score is 14 and the maximum score is 70, with lower scores indicating poorer quality of life. The data presented here summarizes the change in score from baseline to 8 weeks. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)

The QIDS-SR16 is a 16-item rating scale of depressive symptoms completed by the patient at each visit. It is a shorter version of the IDS-C30 that is completed by the patient rather than the examiner. The total score ranges from 0 to 27 (higher score signifies more severe depression) and is obtained by adding the scores for each of the 9 depression symptom domains of the DSM IV. The data presented here summarizes the change in QIDS-SR16 from Baseline to Week 8. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Item 4 assesses hypersomnia on a scale from 0 (sleeps no longer than 7-8 hours a night) to 3 (sleeps longer than 12 hours in 24 hour period). The data presented here summarizes the change from baseline to week 8 in the score of Item 4 assessing hypersomnia. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. Items 1 - 3 assess sleep onset insomnia, mid-nocturnal insomnia, and early morning insomnia respectively each on a 0 - 3 scale. The data presented here summarizes the change from baseline to week 8 in the combined score of these three items assessing insomnia. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 8 weeks from start of study drug administration (or last observation after baseline)

The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 1 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 1 week following the start of study drug administration

The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 2 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 2 weeks following the start of study drug administration

The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 3 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 3 weeks following the start of study drug administration

The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 4 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 6 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 6 weeks following the start of study drug administration

The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Week 8 in the total score of the IDS-C30. (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

"Number of Patients Achieving Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"

"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a response (> 50% decrease from baseline in total score)." (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

"Number of Patients Achieving Sustained Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"

"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained remission (total score <= 11 that persists over the four week period from Week 4 to Week 8)." (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

"Number of Patients Achieving Sustained Response at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)"

"The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a sustained response (> 50% decrease from baseline in total score that persisted over the four week period between Week 4 and Week 8)." (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

The IDS C30 is a standardized 30 item, clinician rated, scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data here summarizes the number of subjects in each treatment group who achieved a remission (total score <=11). (NCT00481195)
Timeframe: Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline)

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline)

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Endpoint are presented." (NCT00481195)
Timeframe: Baseline and 8 weeks (or last observation after baseline)

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 1

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 1 are presented." (NCT00481195)
Timeframe: Baseline and 1 week following the start of study drug administration

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 2

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 2 are presented." (NCT00481195)
Timeframe: Baseline and 2 weeks following the start of study drug administration

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 3

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 3 are presented." (NCT00481195)
Timeframe: Baseline and 3 weeks following the start of study drug administration

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 4

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 4 are presented." (NCT00481195)
Timeframe: Baseline and 4 weeks following the start of study drug administration

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 6

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 6 are presented." (NCT00481195)
Timeframe: Baseline and 6 weeks following the start of study drug administration

The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 8

"CGI-BP is a standardized, clinician-rated assessment which allows the clinician to rate the bipolar illness at various time points compared with baseline. At Screening and Baseline visits the physician rated the severity of the illness using 7 categories (1=normal through 7=very severely ill). At subsequent visits the clinician assessed the change in severity of the condition using 7 categories (1=very much improved through 7=very much worse). Subjects were considered responders if they had a rating of much improved or very much improved. The number of responders at Week 8 are presented." (NCT00481195)
Timeframe: Baseline and 8 weeks following the start of study drug administration

Change From Baseline in the Dysphoric Apathy/Retardation Sub-factor (MDAR) of Montgomery-Asberg Depression Rating Scale (MADRS) at 4 Weeks.

The Montgomery-Asberg Depression Rating Scale Dysphoric Apathy Retardation subfactor (MDAR) is a 5-item subscale of the clinician-administered 10-item Montgomery-Asberg Depression Rating Scale (MADRS). MDAR score can range from 0-30 with a higher score representing a greater severity of depressive symptoms. (NCT01148979)
Timeframe: Baseline to 4 weeks of treatment

Reviews

10 reviews available for modafinil and Depression, Involutional

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15 trials available for modafinil and Depression, Involutional

Other Studies

21 other studies available for modafinil and Depression, Involutional