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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
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This study was designed to use a sensitive neuroendocrine probe, the Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults with insomnia. The primary aim was to assess cortisol reactivity before and after long-term (6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone would result in a significant reduction in plasma cortisol response to the DEX/CRH test following treatment of insomnia with standard dose of eszopiclone.
see above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label Eszopiclone | Experimental | Standard dosing of drug for 6 weeks for insomnia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eszopiclone | Drug | 6 weeks standard oral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug) | Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT). | post drug (6 weeks oral eszopiclone) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Carpenter, MD | Butler Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
Excluded subjects met criteria for current major depressive disorder (MDD) or other major Axis I psychiatric or substance use disorders. Subjects reporting < 6 hours of sleep/night and with score > 10 on Insomnia Severity Index (ISI) qualified. General good health required on physical and neurological examinations and on laboratory studies.
Subjects were recruited from the community via flyers and through Internet and newspaper advertisements for "healthy adults experiencing problems with sleep." Voluntary written informed consent was obtained for the study, which was approved by the Butler Hospital Institutional Review Board.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Eszopiclone | Standard daily dosing of 3 mg drug nightly for 6 weeks for insomnia eszopiclone : 6 weeks standard oral therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-label Eszopiclone | Standard dosing of drug for 6 weeks for insomnia eszopiclone : 6 weeks standard oral therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug) | Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT). | All subjects completed all study procedures | Posted | Mean | Standard Deviation | nmol/L | post drug (6 weeks oral eszopiclone) | paired t-test cortisol reactivity | paired t-test cortisol reactivity |
|
|
Over 6 weeks on drug; verbal report by subject at clinic assessments every 2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-label Eszopiclone | Standard dosing of drug for 6 weeks for insomnia eszopiclone : 6 weeks standard oral therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Carpenter, MD | Butler Hospital | 401 455 6349 | Linda_Carpenter_MD@Brown.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Depressive Symptoms | Inventory for Depressive Symptomology-Self Report version (IDS-SR), total score calculated without 4 items pertaining to sleep. Range of scores on this version of the IDSSR are 0 (best outcome; no symptoms) to 69 (worst outcome; severe symptoms). | Mean | Standard Deviation | scores on a scale |
|
| plasma cortisol response to standardized dexamethasone/Corticotropin Releasing Hormone (DEX/CRH) | Cortisol assays were performed on plasma samples from 2:59 PM (baseline), 3:30 PM, 3:45 PM, 4:00 PM, 4:15 PM, and 5:00 PM. Radioimmunoassay (RIA) used to measure cortisol in duplicate at each time point; intra-assay and inter-assay coefficients of variation observed for quality assessment samples (5 and 20 nmol/L) were <5% and 10%, respectively. Cortisol "response"was summarized by absolute change from pre-CRH infusion (time point 0) to peak level after CRH infusion. | Mean | Standard Deviation | nmol/L |
|
| Insomnia Severity Index | Self report measure of Insomnia. Subjects had to have a total score >10 to enroll. The range of the scales is from 0 (no insomnia symptoms) to 28 (severe insomnia symptoms). | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
| paired t-test cortisol reactivity |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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| D001523 |
| Mental Disorders |
| D011725 |
| Pyridines |