gamma-aminobutyric acid and Fibromyalgia

gamma-aminobutyric acid has been researched along with Fibromyalgia in 131 studies

gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.
gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.

Fibromyalgia: A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95)

Research

Studies (131)

Authors

Clinical Trials (63)

Trial Overview

Trial Outcomes

Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep

The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 6

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Double Blind End Point Visit (Week 19)

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Double Blind End Point Visit (Week 19)

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Double Blind End Point Visit (Week 19)

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19)

"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment- Total Sleep Time at Double Blind End Point Visit (Week 19)

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)

Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit

The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit

Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep

The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 19

Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period)

Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Week 19

Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event

Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response. (NCT01271933)
Timeframe: Randomization to Week 19

Double-Blind Phase: Time to Loss of Therapeutic Response (LTR)

The time to loss of therapeutic response (LTR) is the time to loss of pain response (<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase). (NCT01271933)
Timeframe: Randomization to Week 19

Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period)

Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Week 6

Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II

The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 6

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15

"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)

Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Double-Blind Phase: Change From Baseline in FIQ Score at Week 19

The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment. (NCT01271933)
Timeframe: Baseline, Week 19

Double-Blind Phase: Change From Baseline in HADS Score at Week 19

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01271933)
Timeframe: Baseline, Week 19

Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II

The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 19

Double-Blind Phase: Change From Baseline in MFI Score at Week 19

The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction. (NCT01271933)
Timeframe: Baseline, Week 19

Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life. (NCT01271933)
Timeframe: Baseline, Week 19

Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19

WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. (NCT01271933)
Timeframe: Baseline, Week 19

Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19

PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT01271933)
Timeframe: Week 19

Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19

The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. (NCT01271933)
Timeframe: Week 19

Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA)

C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm. (NCT01271933)
Timeframe: Week 1 to Week 7 and Week 11 to Week 20

Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA)

C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm. (NCT01271933)
Timeframe: Week 1 to Week 7 and Week 11 to Week 20

Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life. (NCT01271933)
Timeframe: Baseline, Week 6

Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7

"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6

The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6

The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment. (NCT01271933)
Timeframe: Baseline, Week 6

Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01271933)
Timeframe: Baseline, Week 6

Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6

Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6

The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction. (NCT01271933)
Timeframe: Baseline, Week 6

Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6

WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. (NCT01271933)
Timeframe: Baseline, Week 6

Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6

PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT01271933)
Timeframe: Week 6

Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6

The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. (NCT01271933)
Timeframe: Week 6

Adherence to Mobile Application Assessed by Number of Clicks on the App Functions

Number of clicks on the app functions (NCT03004911)
Timeframe: 6 weeks

Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire

Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome. (NCT03004911)
Timeframe: 6 weeks

Number of Painful Areas Assessed With the Widespread Pain Index

Minimum value: 0. Maximum value: 19. (NCT03004911)
Timeframe: 6 weeks

Pain Assessed With the Visual Analogue Scale

Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome. (NCT03004911)
Timeframe: 6 weeks

Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised

Minimum value: 15. Maximum value: 75. Higher scores mean better outcome. (NCT03004911)
Timeframe: 6 weeks

Severity of Symptoms Assessed With the Symptom Severity Scale

Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome. (NCT03004911)
Timeframe: 6 weeks

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14

FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)

Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)

Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14

MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue). (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14

Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain. (NCT00333866)
Timeframe: Baseline, Week 14

Percentage of Participants With Optimal Sleep Assessed Using MOS-SS

Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more disturbance. (NCT00333866)
Timeframe: Baseline, Week 14

Total Daily Acetaminophen Dose

Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days). (NCT00333866)
Timeframe: Week 14

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14

FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14

Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Weekly Mean Sleep Quality Score

Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries. (NCT00333866)
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

Patient Global Impression of Change (PGIC)

Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00333866)
Timeframe: Week 14

Latency to Persistent Sleep (LPS)

LPS, as determined by PSG, was the total number of epochs recorded on 2 consecutive nights divided by 2 at the end of each intervention period, from the beginning of the recording to the start of the first 20 consecutive non-wake epochs. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

Number of Awakenings After Sleep Onset (NAASO 1)

NAASO 1, as determined by PSG, was the number of times there was a wake period of at least one epoch in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage rapid eye movement (REM) epoch. The sum of 2 consecutive nights of recording was divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

Number of Awakenings After Sleep Onset (NAASO 2)

NAASO 2, as determined by PSG, was the number of times that there was a wake period of at least two epochs in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage REM epoch. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

Sleep Efficiency (SE)

SE, as determined by PSG, was the TST divided by the time in bed, multiplied by 100. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

Slow Wave Sleep (SWS)

SWS, as determined by PSG, Stage 3 plus 4 sleep divided by TST times 100 was the percentage of TST. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

Total Sleep Time (TST)

TST, as determined by PSG, was the number of non-wake epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

Wake After Sleep Onset (WASO) at Weeks 5 and 11

WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]) on 2 consecutive nights divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)

Wake Time After Sleep (WTAS)

WTAS, as determined by PSG, was the total amount of time awake after the final awakening until the end of the 8 hours. WTAS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

Wake Time During Sleep (WTDS)

WTDS, as determined by PSG, was the total amount of time awake the participant experienced after the onset of persistent sleep and prior to the final awakening, or at the end of 8 hours of recording. WTDS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11

MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was comprised of 12 items yielding 7 subscale scores and 2 index composite index scores. Sleep Disturbance subscale score (4 items): individual scores were transformed (actual raw score minus lowest possible score divided by possible raw score range times 100) and ranged from 0 to 100; higher score indicated greater disturbance. Total score ranged=0 to 100; higher score indicates greater intensity of attribute. Change was score at week x minus score at baseline. (NCT00883740)
Timeframe: Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET

Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11

MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was compromised of 12 items yielding 7 subscale scores and 2 index composite index scores. Composite index included Sleep Problems Index II (9 items), scores ranged from 0 to 100; higher scores indicated greater sleep problems. Change was score at week x minus score at baseline. (NCT00883740)
Timeframe: Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET

Daily Pain Score

Pain intensity as measured by NRS; a participant rated scale 0 to 10 (0 = no pain to 10 = worst pain possible). Weekly values were calculated as the average of the participants daily pain scores. (NCT00883740)
Timeframe: Daily up to Day 73 or ET

Latency of Sleep Onset (LSO)

LSO as reported on daily Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the amount of time to fall asleep after lights out. Weekly values were calculated as the average minutes reported on the participant's daily SSQ. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET

Sleep Quality

Sleep Quality as meassured by numeric rating scale (NRS), a participant rated scale 0 to 10, (0 = very poor sleep, 10 = excellent sleep). Weekly values were calculated as the average of the participants daily diary scores. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET

Subjective Total Sleep Time (sTST)

sTST as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Weekly values were calculated as the average of the participants daily SSQ values. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET

Subjective Wake After Sleep Onset (sWASO)

sWASO as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. Weekly values were calculated as the average of the participant's daily SSQ values. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET

WASO by Each Quarter of the Night

WASO, as determined by PSG, was the sum of wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual quarter of the night (eight hours in 2 hour increments). (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

WASO by Hour of the Night

WASO, as determined by PSG, was the wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual hour (8 hours total). (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET

Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score

"Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 no pain to 100 worst possible pain. Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind." (NCT00346034)
Timeframe: Week 12 (end of treatment)

Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score

"Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 no pain to 100 worst possible pain. Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind." (NCT00346034)
Timeframe: Week 4

"Percentage of Participants Who Was Categorized as Improved (Very Much Improved, Much Improved, or a Minimally Improved) According to the Patient Global Impressions of Change (PGIC)"

PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale. (NCT00830167)
Timeframe: Week 15 or study discontinuation

Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline

Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss

FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety

Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression

Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache

MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index

MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep

MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy

MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance

MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring

MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence

MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint

The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Change From Baseline in Sleep Quality Score at Endpoint

Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation

Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint

MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night. (NCT00830167)
Timeframe: Week 15 or study discontinuation

Fibromyalgia Impact Questionnaire (FIQ)

The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status. (NCT02052414)
Timeframe: 15 weeks.

Medical Outcome Study (MOS) Sleep Questionnaires

"Medical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas.~Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5)." (NCT02052414)
Timeframe: 15 weeks

Numeric Pain Rating System (NPRS)

Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable). (NCT02052414)
Timeframe: 15 weeks

Patient Global Impression of Change (PGIC)

Patient Global impression of Change (PGIC) is an outcome commonly used measure of the efficacy of treatments. PGIC is a 7 point scale that requires the subjects to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT02052414)
Timeframe: 15 Weeks.

Self Reported Side Effects.

Side / adverse effects were assessed at each follow up visits and resulted are as follows. (NCT02052414)
Timeframe: 15 Weeks

Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)

"The evaluation of the pain intensity was based on a 11-point Numerical Pain Rating Scale (NPRS score from 0= no pain to 10= the most intense pain imaginable). Patients recorded the NPRS score every day of treatment in their diary.~The improvement in the pain intensity is defined as a decrease in NPRS scores from baseline to the end of treatment." (NCT03720119)
Timeframe: Every day for 15 days

Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)

"The evaluation of wound pain relief was based on a 5-point Visual Rating Scale (0 = none improvement; 4 = total relief).~Patients recorded the VRS score every day of treatment in their diary. The improvement in the pain relief was defined as a VRS scores at end of treatment significantly greater than 0." (NCT03720119)
Timeframe: Every day for 15 days

Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome

Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score. (NCT02232282)
Timeframe: 0 weeks, 6 weeks

Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome

The total number of adverse events experienced by women receiving acupuncture (NCT02232282)
Timeframe: 0 weeks, 12 weeks

Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom

The total number of acupuncture sessions stopped due to poor tolerability of acupuncture (NCT02232282)
Timeframe: 0 weeks, 6 weeks

Change in Functionality Evaluated With Specific Questionnaire

The Brazilian version of Shoulder Pain and Disability Index ranging 0 to 100 points. Lower scores indicate better functionality (NCT02695524)
Timeframe: baseline, four and eight weeks and sixteen weeks after randomization

Change in Intensity of Pain Evaluated by a Scale

Pain Numerical Rating Scale from 0 to 10. Lower values indicate improvement in pain (NCT02695524)
Timeframe: baseline, four and eight weeks and sixteen weeks after randomization

Change in Kinesiophobia Evaluated With Specific Questionnaire

Tampa Scale of Kinesiophobia ranging 17 to 68 points. High scores indicate high degree kinesiophobia (NCT02695524)
Timeframe: baseline, four and eight weeks and sixteen weeks after randomization

Change in Strength Evaluated by Hand Held Dynamometer and the Measures Provided in Kilogram-force (KgF)

Strength of serratus anterior, trapezius muscles, abduction, adduction, internal and external rotation movements the arm with hand held Dynamometer. (NCT02695524)
Timeframe: baseline, four and eight weeks and sixteen weeks after randomization

Perceived Change Evaluated by Numerical Scale

Global Perceived Effect Scale ranging -5 to +5 points. Positive values indicate improvement and negative values indicate worsening of symptoms (NCT02695524)
Timeframe: four, eight weeks and sixteen weeks of randomization

Range of Motion Evaluated by Digital Inclinometer and the Measures Provided in Degrees

abduction, adduction, internal and external rotation of the shoulder (NCT02695524)
Timeframe: baseline, four and eight weeks and sixteen weeks after randomization

Satisfaction With Treatment Evaluated With Specific Questionnaire

Medrisk Questionnaire ranging 13 to 80 points. High scores indicate satisfaction with treatment (NCT02695524)
Timeframe: four, eight weeks and sixteen weeks after randomization

Scapula Position Evaluated by Digital Inclinometer and the Measures Provided in Degrees

upward rotation and tilt of the scapula (NCT02695524)
Timeframe: baseline, four and eight weeks and sixteen weeks after randomization

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