A Phase 2 interventional study of eszopiclone and eszopiclone in Generalized Anxiety Disorder, sponsored by Sumitomo Pharma America, Inc.. Completed at 57 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-04-08.
Sponsored by Sumitomo Pharma America, Inc. · Phase 2, Interventional, and Treatment
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
This is a multicenter, randomized, double blind, placebo controlled study of the safety and efficacy of SEP-225441 (eszopiclone) in male and female adult subjects with a diagnosis of generalized anxiety disorder (GAD). The study consists of a screening period of 7-10 days, 8 weeks of treatment, and a 7 day follow-up period. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 456 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
Drug: eszopiclone
SEP-225441 (eszopiclone) total daily dose of 0.9 mg
Drug: eszopiclone
Placebo total daily dose 0.9 mg
Drug: Placebo
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
Also known as: SEP-225441
SEP-225441 (eszopiclone) total daily dose of 0.9 mg
Also known as: SEP-225441
Placebo total daily dose 0.9 mg
Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater
THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
Time frame: Baseline to Week 8
Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8)
The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. all items are measured on a 5-point scale (0-4). Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
Time frame: Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF)
Change in Individual Item Scores on HAM-A
The HAM-A was administered by a site trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a t5-point scale (0-4). Each HAM-A individual item score can range from 0 to 4 with higher scores indicating higher severity of anxiety questions.
Time frame: Baseline, Weeks 2, 4, 6, 8
Change From Baseline in Clinician Global Impression of Severity (CGI-S)
The CGI-Swas completed by a board certified psychiatrist and represents the clinician's subjective assessment of severity of the subject's anxiety symptoms as assessed by a 7-scale score for a single question, "Considering your total clinical experience with this particular population, how anxious is the subject at this time?" The score was based on the following scale: 1=normal, not at all anxious; 2=borderline anxious; 3=mildly anxious; 4=moderately anxious; 5=markedly anxious; 6=severly anxious; 7=among the most extremely anxious subjects. CGI-S score can range from 0 to 7, with higher values indicating higher severity.
Time frame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)
Clinical Global Impression- Improvement (CGI-I)
CGI-I was completed by a board certified psychiatrist and represented the clinician's subjective assessment of improvement of the subject's anxiety symptoms based on the following question, "Compared to his/her condition at Visit 2, how much has he/she changed?" The score was based on the following scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. CGI-I score can range from 0 to 7, with higher values indicating less improvement.
Time frame: Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF)
Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response
The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). A 50% anxiolytic response was defined as a 50% or greater reduction from baseline in the HAM-A total score. The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
Time frame: Week 2, 4, 6, 8
Hamilton Anxiety Scale (HAM-A) Remission
The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). Remission was defined as a HAM-A total score of 7 or less. The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
Time frame: Week 2, 4, 6, 8 based on last observation carried forward (LOCF)
Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form
The Q-LES-Q was completed by the subject and assessed quaility of life based on 16 items, each evaluated on a 5-point scale of overall level of enjoyment/satisfaction: 1=very poor; 2=poor; 3=fair; 4=good; 5=very good. The overall percentage score was computed as a sum of items 1 to 14 as expressed as a percentage of the maximum possible score: Overall Percentage Score = Sum \[item 1... item 14\]-14)/(70-14 ) \*100%. Q-LES-Q overall percentage score can range from 0 to 100, with higher values indicating higher quality of life.
Time frame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)
Change From Baseline Insomnia Severity Index (ISI) Total Score
The ISI was completed by the subject and is an assessment of the severity of insomnia. The administered extended ISI questionnaire consists of 5 items (containing 7 questions, as item 1 contains 3 questions) comprising the original ISI questionnaire, plus 6 quality of life related items (sleep quality, restedness/refreshness upon arising, daytime fatigue, attention/concentration, relationships and mood disturbances), and 2 items assessing duration and frequency of sleep problems. All items, except for the insomnia duration and frequency questions, are measured on a Likert-type 5-point scale (0-4). ISI total score can range from 0 to 28, with higher scores indicating more severe insomnia.
Time frame: Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF)
Change From Baseline Sheehan Disability Scale (SDS)
The SDS was completed by the subject and captured the subject's level of disability. The subject rated the extent to which his or her work, social life or leisure activities, and home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. SDS total score can range from 0 to 30, with higher scores indicating higher functional impairment.
Time frame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)
Change From Baseline Epworth Sleepiness Scale (ESS)
ESS was completed by the subject and assessed daytime sedation based on 8 items, each presenting a situation for which the subject needed to evaluate how likely he/she is to doze off or fall asleep in contrast to feeling just tired. Each item was evaluated on the following scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. ESS total score can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.
Time frame: Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF)
| Milestone | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Started | 152 | 153 | 151 |
| Completed | 117 | 112 | 103 |
| Not completed | 35 | 41 | 48 |
| Withdrew: Adverse event | 10 | 7 | 12 |
| Withdrew: Lack of efficacy | 5 | 5 | 5 |
| Withdrew: Lost to follow-up | 3 | 12 | 10 |
| Withdrew: Protocol violation | 2 | 4 | 3 |
| Withdrew: Withdrawal by subject | 9 | 7 | 11 |
| Withdrew: Does not meet in/ex criteria | 0 | 0 | 2 |
| Withdrew: Other | 6 | 6 | 5 |
THe HAM-M was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-M rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
| Units on a scale | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater | -10.0 ± 7.0 | -9.3 ± 7.4 | -9.5 ± 8.1 |
The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items included: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. all items are measured on a 5-point scale (0-4). Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
| unit on a scale | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Baseline | 24.2 ± 3.4 | 24.0 ± 3.4 | 24.0 ± 3.7 |
| Week 2 - Change from baseline | -5.7 ± 5.7 | -4.8 ± 5.0 | -6.0 ± 6.1 |
| Week 4-Change from baseline | -8.1 ± 6.0 | -7.6 ± 6.3 | -8.0 ± 6.8 |
| Week 6- Change from baseline | -8.9 ± 6.3 | -8.7 ± 7.2 | -8.5 ± 7.4 |
The HAM-A was administered by a site trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a t5-point scale (0-4). Each HAM-A individual item score can range from 0 to 4 with higher scores indicating higher severity of anxiety questions.
| units on a scale | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Anxious Mood-Baseline | 2.8 ± 0.5 | 2.8 ± 0.5 | 2.8 ± 0.5 |
| Anxious Mood-Week 2 -Change from baseline | -0.6 ± 0.8 | -0.5 ± 0.7 | -0.6 ± 0.9 |
| Anxious Mood-Week 4 - Change from baseline | -0.8 ± 0.9 | -0.8 ± 0.8 | -0.9 ± 1.0 |
| Anxious Mood-Week 6 - Change from baseline | -1.0 ± 0.9 | -0.8 ± 0.8 | -1.0 ± 1.0 |
| Anxious Mood-Week 8- Change from baseline | -1.0 ± 1.0 | -0.9 ± 0.9 | -1.1 ± 1.1 |
| Tension - Baseline | 2.7 ± 0.5 | 2.6 ± 0.5 | 2.7 ± 0.5 |
| Tension - Week 2 -Change from baseline | -0.5 ± 0.9 | -0.4 ± 0.7 | -0.6 ± 0.9 |
| Tension - Week 4 - Change from baseline | -0.8 ± 1.0 | -0.6 ± 0.9 | -0.8 ± 0.9 |
| Tension - Week 6- Change from baseline | -0.9 ± 1.0 | -0.8 ± 1.0 | -1.0 ± 1.0 |
| Tension - Week 8- Change from baseline | -0.9 ± 1.0 | -0.9 ± 1.0 | -1.0 ± 1.0 |
| Fears- Baseline | 1.1 ± 1.1 | 1.2 ± 1.0 | 1.0 ± 0.9 |
| Fears- Week 2- Change from baseline | -0.3 ± 0.9 | -0.4 ± 0.8 | -0.2 ± 0.8 |
| Fears- Week 4- Change from baseline | -0.4 ± 0.9 | -0.5 ± 0.9 | -0.3 ± 0.8 |
| Fears- Week 6- Change from baseline | -0.4 ± 1.0 | -0.5 ± 0.9 | -0.4 ± 0.9 |
| Fears- Week 8- Change from baseline | -0.5 ± 0.9 | -0.7 ± 1.0 | -0.4 ± 0.9 |
| Insomnia- Baseline | 2.5 ± 0.7 | 2.5 ± 0.7 | 2.6 ± 0.8 |
| Insomnia- Week 2- Change from baseline | -0.5 ± 0.9 | -0.5 ± 1.0 | -0.8 ± 1.0 |
| Insomnia- Week 4- Change from baseline | -0.8 ± 1.1 | -0.8 ± 1.0 | -0.9 ± 1.0 |
| Insomnia- Week 6- Change from baseline | -0.8 ± 1.0 | -0.8 ± 1.0 | -0.9 ± 1.1 |
| insomnia- Week 8- Change from baseline | -0.9 ± 1.1 | -0.8 ± 1.0 | -1.0 ± 1.2 |
| Intellectual- Baseline | 2.1 ± 0.8 | 2.1 ± 0.8 | 2.2 ± 0.8 |
| Intellectual- Week 2- Change from baseline | -0.4 ± 0.9 | -0.4 ± 0.9 | -0.5 ± 0.9 |
| Intellectual- Week 4- Change from baseline | -0.8 ± 1.0 | -0.6 ± 0.9 | -0.7 ± 0.9 |
| Intellectual- Week 6- Change from baseline | -0.7 ± 1.1 | -0.7 ± 1.0 | -0.8 ± 1.1 |
| Intellectual- Week 8- Change from baseline | -0.9 ± 1.1 | -0.8 ± 1.1 | -0.9 ± 1.1 |
| Depressed Mood- Baseline | 1.1 ± 0.8 | 1.2 ± 0.7 | 1.0 ± 0.7 |
| Depressed Mood- Week 2- Change from baseline | -0.3 ± 0.8 | -0.2 ± 0.8 | -0.2 ± 0.8 |
| Depressed Mood- Week 4- Change in baseline | -0.4 ± 0.9 | -0.3 ± 0.9 | -0.3 ± 0.8 |
| Depressed Mood- Week 6- Change from baseline | -0.3 ± 0.9 | -0.3 ± 0.9 | -0.3 ± 0.8 |
| Depressed Mood- Week 8- Change from baseline | -0.4 ± 0.9 | -0.4 ± 0.9 | -0.3 ± 0.9 |
| Somatic Complaints-Muscular-Baseline | 2.0 ± 0.8 | 1.9 ± 0.8 | 1.8 ± 0.8 |
| Somatic Complaints-Muscular-Wk 2-Chg from baseline | -0.5 ± 1.0 | -0.3 ± 0.8 | -0.5 ± 0.8 |
| Somatic Complaints-Muscular-Wk 4-Chg from baseline | -0.7 ± 0.9 | -0.5 ± 1.0 | -0.6 ± 0.9 |
| Somatic Complaints-Muscular-Wk 6-Chg from baseline | -0.8 ± 1.1 | -0.7 ± 1.1 | -0.6 ± 1.0 |
| Somatic Complaints-Muscular-Wk 8-Chg from baseline | -0.9 ± 1.1 | -0.7 ± 1.1 | -0.7 ± 1.1 |
| Somatic Complaints-Sensory-Baseline | 1.0 ± 0.9 | 1.0 ± 0.9 | 1.2 ± 0.9 |
| Somatic Complaints-Sensory-Wk 2-Chg from baseline | -0.3 ± 0.9 | -0.2 ± 0.8 | -0.5 ± 1.0 |
| Somatic Complaints-Sensory-Wk 4-Chg from baseline | -0.4 ± 0.9 | -0.3 ± 1.0 | 1.0 ± 0.9 |
| Somatic Complaints-Sensory-Wk 6-Chg from baseline | -0.4 ± 0.9 | -0.4 ± 0.9 | -0.5 ± 1.0 |
| Somatic Complaints-Sensory-Wk 8-Chg from baseline | -0.5 ± 1.0 | -0.4 ± 1.0 | -0.5 ± 1.0 |
| Cardiovascular symptoms-baseline | 1.1 ± 1.0 | 1.2 ± 1.0 | 1.3 ± 1.0 |
| Cardiovascular symptoms-Wk 2-Chg. from baseline | -0.4 ± 1.0 | -0.4 ± 0.9 | -0.5 ± 1.0 |
| Cardiovascular symptoms-Wk 4-Chg. from baseline | -0.5 ± 1.0 | -0.7 ± 1.0 | -0.6 ± 1.0 |
| Cardiovascular symptoms-Wk 6-Chg. from baseline | -0.6 ± 1.0 | -0.6 ± 1.0 | -0.6 ± 1.0 |
| Cardiovascular symptoms-Wk 8-Chg. from baseline | -0.7 ± 1.0 | -0.8 ± 1.0 | -0.7 ± 1.1 |
| Respiratory Symptoms-Baseline | 1.2 ± 0.9 | 1.2 ± 0.9 | 1.3 ± 0.9 |
| Respiratory Symptoms-Wk 2 Change from baseline | -0.4 ± 0.9 | -0.3 ± 0.8 | -0.4 ± 0.9 |
| Respiratory Symptoms-Wk 4 Change from baseline | -0.5 ± 0.9 | -0.5 ± 0.9 | -0.5 ± 1.0 |
| Respiratory Symptoms-Wk 6 Change from baseline | -0.6 ± 0.9 | -0.5 ± 1.0 | -0.5 ± 1.1 |
| Respiratory Symptoms-Wk 8 Change from baseline | -0.6 ± 0.9 | -0.6 ± 0.9 | -0.7 ± 1.0 |
| Gastrointestinal Symptoms- Baseline | 1.4 ± 1.0 | 1.4 ± 1.0 | 1.3 ± 0.9 |
| Gastrointestinal Symptoms-Wk2-Change from baseline | -0.3 ± 1.1 | -0.4 ± 1.0 | -0.3 ± 1.1 |
| Gastrointestinal Symptoms-Wk4-Change from baseline | -0.5 ± 1.0 | -0.5 ± 1.0 | -0.4 ± 1.1 |
| Gastrointestinal Symptoms-Wk6-Change from baseline | -0.6 ± 1.0 | -0.6 ± 1.0 | -0.5 ± 1.1 |
| Gastrointestinal Symptoms-Wk8-Change from baseline | -0.6 ± 1.0 | -0.6 ± 1.0 | -0.5 ± 1.1 |
| Genitourinary Symptoms-Baseline | 1.5 ± 1.0 | 1.4 ± 1.0 | 1.4 ± 1.1 |
| Genitourinary Symptoms-Wk 2-Change from baseline | -0.4 ± 1.0 | -0.2 ± 1.0 | -0.3 ± 1.0 |
| Genitourinary Symptoms-Wk 4-Change from baseline | -0.4 ± 1.1 | -0.4 ± 1.1 | -0.4 ± 1.1 |
| Genitourinary Symptoms-Wk 6-Change from baseline | -0.5 ± 1.1 | -0.4 ± 1.1 | -0.3 ± 1.0 |
| Genitourinary Symptoms-Wk 8-Change from baseline | -0.6 ± 1.1 | -0.5 ± 1.1 | -0.4 ± 1.1 |
| Autonomic Symptoms-Baseline | 1.8 ± 0.9 | 1.8 ± 0.8 | 1.8 ± 0.8 |
| Autonomic Symptoms-Wk 2-Change from baseline | -0.4 ± 0.9 | -0.3 ± 0.9 | -0.4 ± 1.0 |
| Autonomic Symptoms-Wk 4-Change from baseline | -0.5 ± 1.0 | -0.5 ± 1.2 | -0.5 ± 0.9 |
| Autonomic Symptoms-Wk 6-Change from baseline | -0.6 ± 1.0 | -0.6 ± 1.1 | -0.6 ± 1.0 |
| Autonomic Symptoms-Wk 8-Change from baseline | -0.8 ± 1.1 | -0.7 ± 1.2 | -0.6 ± 1.0 |
| Behavior at Interview-Baseline | 1.8 ± 0.7 | 1.8 ± 0.6 | 1.8 ± 0.6 |
| Behavior at Interview-Wk 2- Change from baseline | -0.4 ± 0.8 | -0.3 ± 0.7 | -0.4 ± 0.8 |
| Behavior at Interview-Wk 4- Change from baseline | -0.6 ± 0.7 | -0.6 ± 0.8 | -0.5 ± 0.7 |
| Behavior at Interview-Wk 6- Change from baseline | -0.7 ± 0.8 | -0.7 ± 0.8 | -0.7 ± 0.8 |
| Behavior at Interview-Wk 8- Change from baseline | -0.8 ± 0.8 | -0.6 ± 0.9 | -0.7 ± 0.9 |
The CGI-Swas completed by a board certified psychiatrist and represents the clinician's subjective assessment of severity of the subject's anxiety symptoms as assessed by a 7-scale score for a single question, "Considering your total clinical experience with this particular population, how anxious is the subject at this time?" The score was based on the following scale: 1=normal, not at all anxious; 2=borderline anxious; 3=mildly anxious; 4=moderately anxious; 5=markedly anxious; 6=severly anxious; 7=among the most extremely anxious subjects. CGI-S score can range from 0 to 7, with higher values indicating higher severity.
| units on a scale | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Baseline | 4.4 ± 0.5 | 4.3 ± 0.5 | 4.4 ± 0.6 |
| Week 2 - Change from baseline | -0.6 ± 0.9 | -0.4 ± 0.6 | -0.7 ± 0.9 |
| Week 4- Change from baseline | -0.9 ± 0.9 | -0.8 ± 0.8 | -1.0 ± 1.1 |
| Week 6- Change from baseline | -1.1 ± 1.0 | -1.0 ± 1.0 | -1.2 ± 1.2 |
| Week 8- Change from baseline | -1.3 ± 1.1 | -1.2 ± 1.1 | -1.3 ± 1.3 |
CGI-I was completed by a board certified psychiatrist and represented the clinician's subjective assessment of improvement of the subject's anxiety symptoms based on the following question, "Compared to his/her condition at Visit 2, how much has he/she changed?" The score was based on the following scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. CGI-I score can range from 0 to 7, with higher values indicating less improvement.
| units on a scale | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Week 2 | 3.2 ± 1.0 | 3.2 ± 0.9 | 3.1 ± 1.0 |
| Week 4 | 2.9 ± 1.0 | 2.9 ± 0.9 | 2.7 ± 1.2 |
| Week 6 | 2.7 ± 1.0 | 2.6 ± 1.1 | 2.7 ± 1.2 |
| Week 8 | 2.6 ± 1.1 | 2.6 ± 1.1 | 2.6 ± 1.2 |
| Week 9 | 2.4 ± 1.1 | 2.5 ± 1.1 | 2.4 ± 1.2 |
The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). A 50% anxiolytic response was defined as a 50% or greater reduction from baseline in the HAM-A total score. The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
| participants | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Week 2 | 21 | 16 | 27 |
| Week 4 | 39 | 41 | 49 |
| Week 6 | 51 | 52 | 53 |
| Week 8 | 63 | 57 | 66 |
The HAM-A was administered by a site-trained rater and measured the severity of the subjects' anxiety symptoms using 14 items of the HAM-A rating scale. These items include: anxious mood, tension, fears, insomnia, intellectual, depressed mood, somatic complaints-muscular, somatic complaints-sensory, cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms, autonomic symptoms, and behavior at interview. All items are measured on a 5-point scale (0-4). Remission was defined as a HAM-A total score of 7 or less. The Ham-A total score can range from 0 to 56 with higher scores indicating higher severity of anxiety symptoms.
| participants | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Week 2 | 7 | 2 | 9 |
| Week 4 | 11 | 10 | 24 |
| Week 6 | 22 | 19 | 23 |
| Week 8 | 31 | 29 | 34 |
The Q-LES-Q was completed by the subject and assessed quaility of life based on 16 items, each evaluated on a 5-point scale of overall level of enjoyment/satisfaction: 1=very poor; 2=poor; 3=fair; 4=good; 5=very good. The overall percentage score was computed as a sum of items 1 to 14 as expressed as a percentage of the maximum possible score: Overall Percentage Score = Sum \[item 1... item 14\]-14)/(70-14 ) \*100%. Q-LES-Q overall percentage score can range from 0 to 100, with higher values indicating higher quality of life.
| units on a scale | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Baseline | 52.4 ± 14.9 | 52.2 ± 13.5 | 52.0 ± 14.8 |
| Week 2- Change from baseline | 3.1 ± 10.6 | 2.1 ± 13.2 | 1.5 ± 12.1 |
| Week 4- Change from baseline | 4.7 ± 12.4 | 5.4 ± 12.7 | 4.6 ± 12.8 |
| Week 6- Change from baseline | 5.8 ± 13.7 | 6.7 ± 13.4 | 5.0 ± 13.6 |
| Week 8- Change from baseline | 7.0 ± 14.8 | 6.8 ± 13.2 | 5.8 ± 14.6 |
The ISI was completed by the subject and is an assessment of the severity of insomnia. The administered extended ISI questionnaire consists of 5 items (containing 7 questions, as item 1 contains 3 questions) comprising the original ISI questionnaire, plus 6 quality of life related items (sleep quality, restedness/refreshness upon arising, daytime fatigue, attention/concentration, relationships and mood disturbances), and 2 items assessing duration and frequency of sleep problems. All items, except for the insomnia duration and frequency questions, are measured on a Likert-type 5-point scale (0-4). ISI total score can range from 0 to 28, with higher scores indicating more severe insomnia.
| units on a scale | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Baseline | 14.6 ± 5.3 | 14.3 ± 5.3 | 14.1 ± 6.0 |
| Week 2- Change from baseline | -2.4 ± 4.4 | -1.5 ± 5.0 | -2.7 ± 5.3 |
| Week 4- Change from baseline | -3.6 ± 4.8 | -3.1 ± 5.4 | -3.4 ± 5.3 |
| Week 6- Change from baseline | -4.0 ± 5.6 | -3.6 ± 5.5 | -3.6 ± 5.6 |
| Week 8- Change from baseline | -4.3 ± 5.6 | -3.5 ± 6.2 | -4.1 ± 5.8 |
The SDS was completed by the subject and captured the subject's level of disability. The subject rated the extent to which his or her work, social life or leisure activities, and home life or family responsibilities were impaired by his or her symptoms on a 10-point visual analog scale. SDS total score can range from 0 to 30, with higher scores indicating higher functional impairment.
| units on a scale | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Baseline | 15.3 ± 6.7 | 14.0 ± 6.4 | 14.8 ± 6.4 |
| Week 2- Change from baseline | -2.5 ± 5.5 | -0.9 ± 6.3 | -2.7 ± 5.3 |
| Week 4- Change from baseline | -3.6 ± 6.1 | -2.5 ± 6.3 | -3.5 ± 6.1 |
| Week 6- Change from baseline | -4.2 ± 6.5 | -3.4 ± 6.3 | -4.1 ± 6.2 |
| Week 8- Change from baseline | -5.1 ± 6.6 | -4.1 ± 6.5 | -4.4 ± 6.2 |
ESS was completed by the subject and assessed daytime sedation based on 8 items, each presenting a situation for which the subject needed to evaluate how likely he/she is to doze off or fall asleep in contrast to feeling just tired. Each item was evaluated on the following scale: 0 = would never doze; 1 = slight chance of dozing; 2 = moderate chance of dozing; 3 = high chance of dozing. ESS total score can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.
| units on a scale | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Baseline | 7.4 ± 4.5 | 8.4 ± 4.5 | 8.5 ± 4.8 |
| Week 2- Change from baseline | -0.1 ± 4.0 | -0.5 ± 3.8 | -0.4 ± 3.6 |
| Week 4- Change from baseline | -0.2 ± 4.6 | -1.0 ± 4.1 | -0.7 ± 4.5 |
| Week 6- Change from baseline | -0.6 ± 4.0 | -1.3 ± 4.0 | -0.9 ± 4.5 |
| Week 8- Change from baseline | -0.8 ± 4.0 | -1.4 ± 4.2 | -1.3 ± 4.5 |
Collected over 10 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Arm | — | 0/149 (0%) | 104/149 (69.8%) |
| Eszopiclone Low Dose Arm | — | 3/146 (2.1%) | 111/146 (76%) |
| Eszopiclone High Dose Arm | — | 0/145 (0%) | 116/145 (80%) |
| Event | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| Amniotic Cavity InfectionInfections and infestations | 0/149 | 1/146 | 0/145 |
| Colon CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/149 | 1/146 | 0/145 |
| Traumatic Brain InjuryInjury, poisoning and procedural complications | 0/149 | 1/146 | 0/145 |
| Self Injurious BehaviorPsychiatric disorders | 0/149 | 1/146 | 0/145 |
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 0/149 | 1/146 | 0/145 |
| Event | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm |
|---|---|---|---|
| DysgeusiaNervous system disorders | 3/149 | 10/146 | 35/145 |
| HeadacheNervous system disorders | 27/149 | 26/146 | 24/145 |
| NauseaGastrointestinal disorders | 14/149 | 7/146 | 18/145 |
| DizzinessNervous system disorders | 6/149 | 11/146 | 16/145 |
| Abdominal Pain UpperGastrointestinal disorders | 10/149 | 9/146 | 14/145 |
| DiarrhoeaGastrointestinal disorders | 11/149 | 5/146 | 13/145 |
| Dry MouthGastrointestinal disorders | 6/149 | 8/146 | 12/145 |
| FatigueGeneral disorders | 12/149 | 12/146 | 4/145 |
| Upper Respiratory Tract InfectionInfections and infestations | 6/149 | 12/146 | 4/145 |
| SomnolenceNervous system disorders | 7/149 | 8/146 | 10/145 |
ITT Population
| Age, Categorical(Participants) | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 149 | 146 | 145 | 440 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm | Total |
|---|---|---|---|---|
| Female | 111 | 108 | 102 | 321 |
| Male | 38 | 38 | 43 | 119 |
| Region of Enrollment(participants) | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm | Total |
|---|---|---|---|---|
| United States | 149 | 146 | 145 | 440 |
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Sumitomo Pharma America, Inc.