Trial · NCT00616655
Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
NCT00616655, Phase 2, Completed, Sumitomo Pharma America, Inc.; results first posted 2015-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects. Trials, record NCT00616655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00616655
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
- NCT number
- NCT00616655
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 456 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Generalized Anxiety Disorder
- Interventions
- eszopiclone, eszopiclone, Placebo
- First posted
- 2008-02-15
- Last updated
- 2016-04-08
- Results first posted
- 2015-08-21
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline to Week 8 | ITT Population: /The ITT population will include all randomized subjects who received at least one does of study medication during the double-blind period. | Units on a scale | MEAN |
| SECONDARY | 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) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | unit on a scale | MEAN |
| SECONDARY | Change in Individual Item Scores on HAM-A | Baseline, Weeks 2, 4, 6, 8 | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinician Global Impression of Severity (CGI-S) | Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impression- Improvement (CGI-I) | Weeks 2, 4, 6, 8, and 9, based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Hamilton Anxiety Scale (HAM-A) 50% Anxiolytic Response | Week 2, 4, 6, 8 | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | participants | NUMBER |
| SECONDARY | Hamilton Anxiety Scale (HAM-A) Remission | Week 2, 4, 6, 8 based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | participants | NUMBER |
| SECONDARY | 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) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline Insomnia Severity Index (ISI) Total Score | Baseline, Weeks 2, 4, 6, 8, based on lst observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline Sheehan Disability Scale (SDS) | Baseline, Weeks 2, 4, 6, 8, based on last observation carried forward (LOCF) | ITT Population: The ITT population will include all randomized subjects who received at least one dose of study medication during the double-blind period. | units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group339
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater | Placebo Arm | -10.0 | Standard Deviation 7.0 | Units on a scale | |
| Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater | Eszopiclone Low Dose Arm | -9.3 | Standard Deviation 7.4 | Units on a scale | |
| Change From Baseline to Week 8 in the Total Score on the Hamilton Anxiety Scale (HAM-A), as Assessed by the Site-trained Rater | Eszopiclone High Dose Arm | -9.5 | Standard Deviation 8.1 | Units on a scale | |
| Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Placebo Arm | Baseline | 24.2 | Standard Deviation 3.4 | unit on a scale |
| Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Eszopiclone Low Dose Arm | Baseline | 24.0 | Standard Deviation 3.4 | unit on a scale |
| Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Eszopiclone High Dose Arm | Baseline | 24.0 | Standard Deviation 3.7 | unit on a scale |
| Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Placebo Arm | Week 2 - Change from baseline | -5.7 | Standard Deviation 5.7 | unit on a scale |
| Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Eszopiclone Low Dose Arm | Week 2 - Change from baseline | -4.8 | Standard Deviation 5.0 | unit on a scale |
| Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Eszopiclone High Dose Arm | Week 2 - Change from baseline | -6.0 | Standard Deviation 6.1 | unit on a scale |
| Change From Baseline Hamilton Anxiety Scale (HAM-A) Total Score (Except for Week 8) | Placebo Arm | Week 4-Change from baseline | -8.1 | Standard Deviation 6.0 | unit on a scale |
1 to 10 of 339Source ClinicalTrials.gov
See all 339 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Arm | 152 | |
| Overall Study | STARTED | Eszopiclone Low Dose Arm | 153 | |
| Overall Study | STARTED | Eszopiclone High Dose Arm | 151 | |
| Overall Study | COMPLETED | Placebo Arm | 117 | |
| Overall Study | COMPLETED | Eszopiclone Low Dose Arm | 112 | |
| Overall Study | COMPLETED | Eszopiclone High Dose Arm | 103 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 35 | |
| Overall Study | NOT COMPLETED | Eszopiclone Low Dose Arm | 41 | |
| Overall Study | NOT COMPLETED | Eszopiclone High Dose Arm | 48 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo Arm | 14 | 149 | 19 |
| other | Nausea | Gastrointestinal disorders | Eszopiclone Low Dose Arm | 7 | 146 | 8 |
| other | Nausea | Gastrointestinal disorders | Eszopiclone High Dose Arm | 18 | 145 | 21 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Arm | 11 | 149 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Eszopiclone Low Dose Arm | 5 | 146 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Eszopiclone High Dose Arm | 13 | 145 | 16 |
| other | Dry Mouth | Gastrointestinal disorders | Placebo Arm | 6 | 149 | 7 |
| other | Dry Mouth | Gastrointestinal disorders | Eszopiclone Low Dose Arm | 8 | 146 | 8 |
| other | Dry Mouth | Gastrointestinal disorders | Eszopiclone High Dose Arm | 12 | 145 | 12 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Placebo Arm | 10 | 149 | 11 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Arm | ||
| Total, all-cause mortality | Eszopiclone Low Dose Arm | ||
| Total, all-cause mortality | Eszopiclone High Dose Arm | ||
| Total, other adverse events | Placebo Arm | 104 | 149 |
| Total, other adverse events | Eszopiclone Low Dose Arm | 111 | 146 |
| Total, other adverse events | Eszopiclone High Dose Arm | 116 | 145 |
| Total, serious adverse events | Placebo Arm | 0 | 149 |
| Total, serious adverse events | Eszopiclone Low Dose Arm | 3 | 146 |
| Total, serious adverse events | Eszopiclone High Dose Arm | 0 | 145 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26488677 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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