Generalized Anxiety Disorder
Conditions
Keywords
Anxiety
Brief summary
To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized anxiety disorder (GAD).
Detailed description
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.
Interventions
DRUGeszopiclone
SEP-225441 (eszopiclone) total daily dose of 1.5 mg
DRUGPlacebo
Placebo total daily dose 0.9 mg
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects must be between 18 and 50 years of age * Subjects must have GAD * Subjects must be in otherwise good general health
Exclusion criteria
* Subject has a documented history of HIV, hepatitis B or hepatitis C. * Subject has a recent history (within 6 months of study entry) or current diagnosis of Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or other disorder. * Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any psychotic, bipolar or schizophrenic disorder. * Subject has presence or history of antisocial personality or other severe disorder * Subject has refractory GAD (previously unresponsive to 2 or more adequate courses of SSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD). * Subject has history of seizures, including febrile seizures. * Subject has initiated psychotherapeutic intervention with 30 days; however, continued psychotherapy is allowed if stable and not specifically directed at GAD. * Subject is undergoing or has undergone electroconvulsive therapy. * Subject is a current smoker or has smoked within the last 12 months. * Subject has donated blood within the past 30 days or plans to donate during and within 30 days after study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater | Baseline to Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Individual Item Scores on HAM-A | Baseline, Weeks 2, 4, 6, 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 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. |
| Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) | 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. |
| Clinical Global Impression- Improvement (CGI-I) | Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF) | 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. |
| Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 2, 4, 6, 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 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. |
| Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Baseline, Weeks 2, 4, 6 based on last observation carried forward (LOCF) | 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. |
| Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) | 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. |
| Change From Baseline Insomnia Severity Index (ISI) Total Score | Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF) | 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. |
| Change From Baseline Sheehan Disability Scale (SDS) | Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) | 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. |
| Change From Baseline Epworth Sleepiness Scale (ESS) | Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) | 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. |
| Hamilton Anxiety Scale (HAM-A) Remission | Week 2, 4, 6, 8 based on last observation carried forward (LOCF) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Arm Placebo | 149 |
| Eszopiclone Low Dose Arm SEP-225441 (eszopiclone) total daily dose of 0.9 mg | 146 |
| Eszopiclone High Dose Arm SEP-225441 (eszopiclone) total daily dose of 1.5 mg | 145 |
| Total | 440 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 10 | 7 | 12 |
| Overall Study | Does not meet in/ex criteria | 0 | 0 | 2 |
| Overall Study | Lack of Efficacy | 5 | 5 | 5 |
| Overall Study | Lost to Follow-up | 3 | 12 | 10 |
| Overall Study | Other | 6 | 6 | 5 |
| Overall Study | Protocol Violation | 2 | 4 | 3 |
| Overall Study | Withdrawal by Subject | 9 | 7 | 11 |
Baseline characteristics
| Characteristic | Placebo Arm | Eszopiclone Low Dose Arm | Eszopiclone High Dose Arm | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 149 Participants | 146 Participants | 145 Participants | 440 Participants |
| Region of Enrollment United States | 149 participants | 146 participants | 145 participants | 440 participants |
| Sex: Female, Male Female | 111 Participants | 108 Participants | 102 Participants | 321 Participants |
| Sex: Female, Male Male | 38 Participants | 38 Participants | 43 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 104 / 149 | 111 / 146 | 116 / 145 |
| serious Total, serious adverse events | 0 / 149 | 3 / 146 | 0 / 145 |
Outcome results
Primary
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
Population: ITT Population: /The ITT population will include all randomized subjects who received at least one does of study medication during the double-blind period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo 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 Units on a scale | Standard Deviation 7 |
| Eszopiclone Low 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 | -9.3 Units on a scale | Standard Deviation 7.4 |
| 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 | -9.5 Units on a scale | Standard Deviation 8.1 |
Secondary
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)
Population: ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 6- Change from baseline | -0.6 units on a scale | Standard Deviation 4 |
| Placebo Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 4- Change from baseline | -0.2 units on a scale | Standard Deviation 4.6 |
| Placebo Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Baseline | 7.4 units on a scale | Standard Deviation 4.5 |
| Placebo Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 2- Change from baseline | -0.1 units on a scale | Standard Deviation 4 |
| Placebo Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 8- Change from baseline | -0.8 units on a scale | Standard Deviation 4 |
| Eszopiclone Low Dose Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 4- Change from baseline | -1.0 units on a scale | Standard Deviation 4.1 |
| Eszopiclone Low Dose Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Baseline | 8.4 units on a scale | Standard Deviation 4.5 |
| Eszopiclone Low Dose Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 2- Change from baseline | -0.5 units on a scale | Standard Deviation 3.8 |
| Eszopiclone Low Dose Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 6- Change from baseline | -1.3 units on a scale | Standard Deviation 4 |
| Eszopiclone Low Dose Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 8- Change from baseline | -1.4 units on a scale | Standard Deviation 4.2 |
| Eszopiclone High Dose Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 8- Change from baseline | -1.3 units on a scale | Standard Deviation 4.5 |
| Eszopiclone High Dose Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 6- Change from baseline | -0.9 units on a scale | Standard Deviation 4.5 |
| Eszopiclone High Dose Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Baseline | 8.5 units on a scale | Standard Deviation 4.8 |
| Eszopiclone High Dose Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 4- Change from baseline | -0.7 units on a scale | Standard Deviation 4.5 |
| Eszopiclone High Dose Arm | Change From Baseline Epworth Sleepiness Scale (ESS) | Week 2- Change from baseline | -0.4 units on a scale | Standard Deviation 3.6 |
Secondary
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)
Population: ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Baseline | 24.2 unit on a scale | Standard Deviation 3.4 |
| Placebo Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Week 6- Change from baseline | -8.9 unit on a scale | Standard Deviation 6.3 |
| Placebo Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Week 4-Change from baseline | -8.1 unit on a scale | Standard Deviation 6 |
| Placebo Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Week 2 - Change from baseline | -5.7 unit on a scale | Standard Deviation 5.7 |
| Eszopiclone Low Dose Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Week 4-Change from baseline | -7.6 unit on a scale | Standard Deviation 6.3 |
| Eszopiclone Low Dose Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Week 2 - Change from baseline | -4.8 unit on a scale | Standard Deviation 5 |
| Eszopiclone Low Dose Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Week 6- Change from baseline | -8.7 unit on a scale | Standard Deviation 7.2 |
| Eszopiclone Low Dose Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Baseline | 24.0 unit on a scale | Standard Deviation 3.4 |
| Eszopiclone High Dose Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Week 6- Change from baseline | -8.5 unit on a scale | Standard Deviation 7.4 |
| Eszopiclone High Dose Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Baseline | 24.0 unit on a scale | Standard Deviation 3.7 |
| Eszopiclone High Dose Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Week 2 - Change from baseline | -6.0 unit on a scale | Standard Deviation 6.1 |
| Eszopiclone High Dose Arm | Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Week 4-Change from baseline | -8.0 unit on a scale | Standard Deviation 6.8 |
Secondary
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)
Population: ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 8- Change from baseline | -1.3 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 4- Change from baseline | -0.9 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Baseline | 4.4 units on a scale | Standard Deviation 0.5 |
| Placebo Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 2 - Change from baseline | -0.6 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 6- Change from baseline | -1.1 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 2 - Change from baseline | -0.4 units on a scale | Standard Deviation 0.6 |
| Eszopiclone Low Dose Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 8- Change from baseline | -1.2 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 6- Change from baseline | -1.0 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 4- Change from baseline | -0.8 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Baseline | 4.3 units on a scale | Standard Deviation 0.5 |
| Eszopiclone High Dose Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 8- Change from baseline | -1.3 units on a scale | Standard Deviation 1.3 |
| Eszopiclone High Dose Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Baseline | 4.4 units on a scale | Standard Deviation 0.6 |
| Eszopiclone High Dose Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 4- Change from baseline | -1.0 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 6- Change from baseline | -1.2 units on a scale | Standard Deviation 1.2 |
| Eszopiclone High Dose Arm | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Week 2 - Change from baseline | -0.7 units on a scale | Standard Deviation 0.9 |
Secondary
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)
Population: ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 2- Change from baseline | -2.4 units on a scale | Standard Deviation 4.4 |
| Placebo Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 6- Change from baseline | -4.0 units on a scale | Standard Deviation 5.6 |
| Placebo Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 8- Change from baseline | -4.3 units on a scale | Standard Deviation 5.6 |
| Placebo Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 4- Change from baseline | -3.6 units on a scale | Standard Deviation 4.8 |
| Placebo Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Baseline | 14.6 units on a scale | Standard Deviation 5.3 |
| Eszopiclone Low Dose Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 4- Change from baseline | -3.1 units on a scale | Standard Deviation 5.4 |
| Eszopiclone Low Dose Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 6- Change from baseline | -3.6 units on a scale | Standard Deviation 5.5 |
| Eszopiclone Low Dose Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 2- Change from baseline | -1.5 units on a scale | Standard Deviation 5 |
| Eszopiclone Low Dose Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 8- Change from baseline | -3.5 units on a scale | Standard Deviation 6.2 |
| Eszopiclone Low Dose Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Baseline | 14.3 units on a scale | Standard Deviation 5.3 |
| Eszopiclone High Dose Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 6- Change from baseline | -3.6 units on a scale | Standard Deviation 5.6 |
| Eszopiclone High Dose Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Baseline | 14.1 units on a scale | Standard Deviation 6 |
| Eszopiclone High Dose Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 2- Change from baseline | -2.7 units on a scale | Standard Deviation 5.3 |
| Eszopiclone High Dose Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 4- Change from baseline | -3.4 units on a scale | Standard Deviation 5.3 |
| Eszopiclone High Dose Arm | Change From Baseline Insomnia Severity Index (ISI) Total Score | Week 8- Change from baseline | -4.1 units on a scale | Standard Deviation 5.8 |
Secondary
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)
Population: ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 6- Change from baseline | 5.8 units on a scale | Standard Deviation 13.7 |
| Placebo Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 8- Change from baseline | 7.0 units on a scale | Standard Deviation 14.8 |
| Placebo Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 4- Change from baseline | 4.7 units on a scale | Standard Deviation 12.4 |
| Placebo Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 2- Change from baseline | 3.1 units on a scale | Standard Deviation 10.6 |
| Placebo Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Baseline | 52.4 units on a scale | Standard Deviation 14.9 |
| Eszopiclone Low Dose Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Baseline | 52.2 units on a scale | Standard Deviation 13.5 |
| Eszopiclone Low Dose Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 4- Change from baseline | 5.4 units on a scale | Standard Deviation 12.7 |
| Eszopiclone Low Dose Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 2- Change from baseline | 2.1 units on a scale | Standard Deviation 13.2 |
| Eszopiclone Low Dose Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 8- Change from baseline | 6.8 units on a scale | Standard Deviation 13.2 |
| Eszopiclone Low Dose Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 6- Change from baseline | 6.7 units on a scale | Standard Deviation 13.4 |
| Eszopiclone High Dose Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 8- Change from baseline | 5.8 units on a scale | Standard Deviation 14.6 |
| Eszopiclone High Dose Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Baseline | 52.0 units on a scale | Standard Deviation 14.8 |
| Eszopiclone High Dose Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 2- Change from baseline | 1.5 units on a scale | Standard Deviation 12.1 |
| Eszopiclone High Dose Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 4- Change from baseline | 4.6 units on a scale | Standard Deviation 12.8 |
| Eszopiclone High Dose Arm | Change From Baseline on Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form | Week 6- Change from baseline | 5.0 units on a scale | Standard Deviation 13.6 |
Secondary
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)
Population: ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Arm | Change From Baseline Sheehan Disability Scale (SDS) | Baseline | 15.3 units on a scale | Standard Deviation 6.7 |
| Placebo Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 6- Change from baseline | -4.2 units on a scale | Standard Deviation 6.5 |
| Placebo Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 4- Change from baseline | -3.6 units on a scale | Standard Deviation 6.1 |
| Placebo Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 8- Change from baseline | -5.1 units on a scale | Standard Deviation 6.6 |
| Placebo Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 2- Change from baseline | -2.5 units on a scale | Standard Deviation 5.5 |
| Eszopiclone Low Dose Arm | Change From Baseline Sheehan Disability Scale (SDS) | Baseline | 14.0 units on a scale | Standard Deviation 6.4 |
| Eszopiclone Low Dose Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 6- Change from baseline | -3.4 units on a scale | Standard Deviation 6.3 |
| Eszopiclone Low Dose Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 2- Change from baseline | -0.9 units on a scale | Standard Deviation 6.3 |
| Eszopiclone Low Dose Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 4- Change from baseline | -2.5 units on a scale | Standard Deviation 6.3 |
| Eszopiclone Low Dose Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 8- Change from baseline | -4.1 units on a scale | Standard Deviation 6.5 |
| Eszopiclone High Dose Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 2- Change from baseline | -2.7 units on a scale | Standard Deviation 5.3 |
| Eszopiclone High Dose Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 6- Change from baseline | -4.1 units on a scale | Standard Deviation 6.2 |
| Eszopiclone High Dose Arm | Change From Baseline Sheehan Disability Scale (SDS) | Baseline | 14.8 units on a scale | Standard Deviation 6.4 |
| Eszopiclone High Dose Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 8- Change from baseline | -4.4 units on a scale | Standard Deviation 6.2 |
| Eszopiclone High Dose Arm | Change From Baseline Sheehan Disability Scale (SDS) | Week 4- Change from baseline | -3.5 units on a scale | Standard Deviation 6.1 |
Secondary
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
Population: ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 2- Change from baseline | -0.4 units on a scale | Standard Deviation 0.8 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 2 Change from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Insomnia- Week 2- Change from baseline | -0.5 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 2-Change from baseline | -0.4 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 8-Chg. from baseline | -0.7 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 6-Chg. from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Fears- Week 6- Change from baseline | -0.4 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 4-Chg. from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | insomnia- Week 8- Change from baseline | -0.9 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Insomnia- Week 4- Change from baseline | -0.8 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-baseline | 1.1 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Intellectual- Baseline | 2.1 units on a scale | Standard Deviation 0.8 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 4-Change from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 8-Chg from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Baseline | 1.1 units on a scale | Standard Deviation 0.8 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 6-Chg from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 6-Change from baseline | -0.5 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 4-Chg from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 6- Change from baseline | -0.7 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 8- Change from baseline | -0.8 units on a scale | Standard Deviation 0.8 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 2-Chg from baseline | -0.3 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 8- Change from baseline | -0.9 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 2-Change from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Baseline | 1.0 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 6- Change from baseline | -0.7 units on a scale | Standard Deviation 0.8 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 8-Chg from baseline | -0.9 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 2- Change from baseline | -0.3 units on a scale | Standard Deviation 0.8 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Baseline | 2.8 units on a scale | Standard Deviation 0.5 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 6-Chg from baseline | -0.8 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 4-Chg from baseline | -0.7 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 6- Change from baseline | -0.3 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 8- Change from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Insomnia- Week 6- Change from baseline | -0.8 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 2-Chg from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Baseline | 2.0 units on a scale | Standard Deviation 0.8 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 4 - Change from baseline | -0.8 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Baseline | 1.8 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 2 -Change from baseline | -0.6 units on a scale | Standard Deviation 0.8 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 2- Change from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 8-Change from baseline | -0.6 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Fears- Week 2- Change from baseline | -0.3 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 4-Change from baseline | -0.4 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 6 - Change from baseline | -1.0 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 4- Change from baseline | -0.8 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Baseline | 1.5 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 8- Change from baseline | -1.0 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 4- Change in baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk8-Change from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Tension - Baseline | 2.7 units on a scale | Standard Deviation 0.5 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 4- Change from baseline | -0.6 units on a scale | Standard Deviation 0.7 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk6-Change from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Tension - Week 2 -Change from baseline | -0.5 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Fears- Week 4- Change from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk4-Change from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Tension - Week 4 - Change from baseline | -0.8 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Baseline | 1.8 units on a scale | Standard Deviation 0.7 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk2-Change from baseline | -0.3 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 8-Change from baseline | -0.8 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms- Baseline | 1.4 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Tension - Week 8- Change from baseline | -0.9 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 2-Chg. from baseline | -0.4 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 8 Change from baseline | -0.6 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Fears- Baseline | 1.1 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Tension - Week 6- Change from baseline | -0.9 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 6-Change from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 6 Change from baseline | -0.6 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Fears- Week 8- Change from baseline | -0.5 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Baseline | 1.2 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 4 Change from baseline | -0.5 units on a scale | Standard Deviation 0.9 |
| Placebo Arm | Change in Individual Item Scores on HAM-A | Insomnia- Baseline | 2.5 units on a scale | Standard Deviation 0.7 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Baseline | 1.9 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Fears- Baseline | 1.2 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Fears- Week 4- Change from baseline | -0.5 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Insomnia- Week 4- Change from baseline | -0.8 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 2- Change from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 4- Change in baseline | -0.3 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 6- Change from baseline | -0.3 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 8-Chg. from baseline | -0.8 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Baseline | 1.2 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 2-Change from baseline | -0.2 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 4-Change from baseline | -0.4 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 6-Change from baseline | -0.4 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Baseline | 2.8 units on a scale | Standard Deviation 0.5 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 2 -Change from baseline | -0.5 units on a scale | Standard Deviation 0.7 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 4 - Change from baseline | -0.8 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 6 - Change from baseline | -0.8 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 8- Change from baseline | -0.9 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Tension - Baseline | 2.6 units on a scale | Standard Deviation 0.5 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Tension - Week 2 -Change from baseline | -0.4 units on a scale | Standard Deviation 0.7 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Tension - Week 4 - Change from baseline | -0.6 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Tension - Week 6- Change from baseline | -0.8 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Tension - Week 8- Change from baseline | -0.9 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Fears- Week 2- Change from baseline | -0.4 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Fears- Week 6- Change from baseline | -0.5 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Fears- Week 8- Change from baseline | -0.7 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Insomnia- Baseline | 2.5 units on a scale | Standard Deviation 0.7 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Insomnia- Week 2- Change from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Insomnia- Week 6- Change from baseline | -0.8 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | insomnia- Week 8- Change from baseline | -0.8 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Intellectual- Baseline | 2.1 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 4- Change from baseline | -0.6 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 6- Change from baseline | -0.7 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 8- Change from baseline | -0.8 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Baseline | 1.2 units on a scale | Standard Deviation 0.7 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 2- Change from baseline | -0.2 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 8- Change from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 2-Chg from baseline | -0.3 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 4-Chg from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 6-Chg from baseline | -0.7 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 8-Chg from baseline | -0.7 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Baseline | 1.0 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 2-Chg from baseline | -0.2 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 4-Chg from baseline | -0.3 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 6-Chg from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 8-Chg from baseline | -0.4 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-baseline | 1.2 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 2-Chg. from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 4-Chg. from baseline | -0.7 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 6-Chg. from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 2 Change from baseline | -0.3 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 4 Change from baseline | -0.5 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 6 Change from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 8 Change from baseline | -0.6 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms- Baseline | 1.4 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk2-Change from baseline | -0.4 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk4-Change from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk6-Change from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk8-Change from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Baseline | 1.4 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 8-Change from baseline | -0.5 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Baseline | 1.8 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 2-Change from baseline | -0.3 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 4-Change from baseline | -0.5 units on a scale | Standard Deviation 1.2 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 6-Change from baseline | -0.6 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 8-Change from baseline | -0.7 units on a scale | Standard Deviation 1.2 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Baseline | 1.8 units on a scale | Standard Deviation 0.6 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 2- Change from baseline | -0.3 units on a scale | Standard Deviation 0.7 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 4- Change from baseline | -0.6 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 6- Change from baseline | -0.7 units on a scale | Standard Deviation 0.8 |
| Eszopiclone Low Dose Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 8- Change from baseline | -0.6 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 4-Chg. from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Insomnia- Week 4- Change from baseline | -0.9 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 4-Change from baseline | -0.4 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 6-Chg. from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Insomnia- Week 2- Change from baseline | -0.8 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Baseline | 1.3 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Insomnia- Baseline | 2.6 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 2- Change from baseline | -0.4 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 2 Change from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Fears- Week 8- Change from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 4-Change from baseline | -0.5 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 4 Change from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Fears- Week 6- Change from baseline | -0.4 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 8-Chg. from baseline | -0.7 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 6 Change from baseline | -0.5 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Tension - Week 8- Change from baseline | -1.0 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Fears- Week 2- Change from baseline | -0.2 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Respiratory Symptoms-Wk 8 Change from baseline | -0.7 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Tension - Week 6- Change from baseline | -1.0 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 6-Change from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms- Baseline | 1.3 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Tension - Week 4 - Change from baseline | -0.8 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-baseline | 1.3 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk2-Change from baseline | -0.3 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Tension - Week 2 -Change from baseline | -0.6 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Fears- Baseline | 1.0 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk4-Change from baseline | -0.4 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Tension - Baseline | 2.7 units on a scale | Standard Deviation 0.5 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 8-Change from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk6-Change from baseline | -0.5 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 8- Change from baseline | -1.1 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 6- Change from baseline | -0.3 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Gastrointestinal Symptoms-Wk8-Change from baseline | -0.5 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 6 - Change from baseline | -1.0 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 8- Change from baseline | -0.7 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Baseline | 1.4 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Baseline | 1.8 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 8- Change from baseline | -0.3 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 2-Change from baseline | -0.3 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 2-Chg from baseline | -0.5 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 4- Change in baseline | -0.3 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 4 - Change from baseline | -0.9 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 4-Chg from baseline | -0.6 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Week 2- Change from baseline | -0.2 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 6-Change from baseline | -0.3 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 6-Chg from baseline | -0.6 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Depressed Mood- Baseline | 1.0 units on a scale | Standard Deviation 0.7 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Week 2 -Change from baseline | -0.6 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Muscular-Wk 8-Chg from baseline | -0.7 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 8- Change from baseline | -0.9 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Baseline | 1.8 units on a scale | Standard Deviation 0.6 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Baseline | 1.2 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 6- Change from baseline | -0.8 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Genitourinary Symptoms-Wk 8-Change from baseline | -0.4 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 2-Chg from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 4- Change from baseline | -0.7 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Anxious Mood-Baseline | 2.8 units on a scale | Standard Deviation 0.5 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 4-Chg from baseline | 1.0 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Intellectual- Week 2- Change from baseline | -0.5 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Fears- Week 4- Change from baseline | -0.3 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 6-Chg from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Intellectual- Baseline | 2.2 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Baseline | 1.8 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Somatic Complaints-Sensory-Wk 8-Chg from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | insomnia- Week 8- Change from baseline | -1.0 units on a scale | Standard Deviation 1.2 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 4- Change from baseline | -0.5 units on a scale | Standard Deviation 0.7 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Behavior at Interview-Wk 6- Change from baseline | -0.7 units on a scale | Standard Deviation 0.8 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Cardiovascular symptoms-Wk 2-Chg. from baseline | -0.5 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Insomnia- Week 6- Change from baseline | -0.9 units on a scale | Standard Deviation 1.1 |
| Eszopiclone High Dose Arm | Change in Individual Item Scores on HAM-A | Autonomic Symptoms-Wk 2-Change from baseline | -0.4 units on a scale | Standard Deviation 1 |
Secondary
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)
Population: ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Arm | Clinical Global Impression- Improvement (CGI-I) | Week 4 | 2.9 units on a scale | Standard Deviation 1 |
| Placebo Arm | Clinical Global Impression- Improvement (CGI-I) | Week 9 | 2.4 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Clinical Global Impression- Improvement (CGI-I) | Week 8 | 2.6 units on a scale | Standard Deviation 1.1 |
| Placebo Arm | Clinical Global Impression- Improvement (CGI-I) | Week 2 | 3.2 units on a scale | Standard Deviation 1 |
| Placebo Arm | Clinical Global Impression- Improvement (CGI-I) | Week 6 | 2.7 units on a scale | Standard Deviation 1 |
| Eszopiclone Low Dose Arm | Clinical Global Impression- Improvement (CGI-I) | Week 9 | 2.5 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Clinical Global Impression- Improvement (CGI-I) | Week 6 | 2.6 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Clinical Global Impression- Improvement (CGI-I) | Week 8 | 2.6 units on a scale | Standard Deviation 1.1 |
| Eszopiclone Low Dose Arm | Clinical Global Impression- Improvement (CGI-I) | Week 2 | 3.2 units on a scale | Standard Deviation 0.9 |
| Eszopiclone Low Dose Arm | Clinical Global Impression- Improvement (CGI-I) | Week 4 | 2.9 units on a scale | Standard Deviation 0.9 |
| Eszopiclone High Dose Arm | Clinical Global Impression- Improvement (CGI-I) | Week 2 | 3.1 units on a scale | Standard Deviation 1 |
| Eszopiclone High Dose Arm | Clinical Global Impression- Improvement (CGI-I) | Week 8 | 2.6 units on a scale | Standard Deviation 1.2 |
| Eszopiclone High Dose Arm | Clinical Global Impression- Improvement (CGI-I) | Week 6 | 2.7 units on a scale | Standard Deviation 1.2 |
| Eszopiclone High Dose Arm | Clinical Global Impression- Improvement (CGI-I) | Week 4 | 2.7 units on a scale | Standard Deviation 1.2 |
| Eszopiclone High Dose Arm | Clinical Global Impression- Improvement (CGI-I) | Week 9 | 2.4 units on a scale | Standard Deviation 1.2 |
Secondary
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
Population: ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 6 | 51 participants |
| Placebo Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 4 | 39 participants |
| Placebo Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 8 | 63 participants |
| Placebo Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 2 | 21 participants |
| Eszopiclone Low Dose Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 8 | 57 participants |
| Eszopiclone Low Dose Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 2 | 16 participants |
| Eszopiclone Low Dose Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 4 | 41 participants |
| Eszopiclone Low Dose Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 6 | 52 participants |
| Eszopiclone High Dose Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 4 | 49 participants |
| Eszopiclone High Dose Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 6 | 53 participants |
| Eszopiclone High Dose Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 2 | 27 participants |
| Eszopiclone High Dose Arm | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 8 | 66 participants |
Secondary
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)
Population: ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 4 | 11 participants |
| Placebo Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 2 | 7 participants |
| Placebo Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 6 | 22 participants |
| Placebo Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 8 | 31 participants |
| Eszopiclone Low Dose Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 8 | 29 participants |
| Eszopiclone Low Dose Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 6 | 19 participants |
| Eszopiclone Low Dose Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 2 | 2 participants |
| Eszopiclone Low Dose Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 4 | 10 participants |
| Eszopiclone High Dose Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 2 | 9 participants |
| Eszopiclone High Dose Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 4 | 24 participants |
| Eszopiclone High Dose Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 6 | 23 participants |
| Eszopiclone High Dose Arm | Hamilton Anxiety Scale (HAM-A) Remission | Week 8 | 34 participants |