Insomnia
Conditions
Brief summary
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.
Detailed description
see above
Interventions
DRUGeszopiclone
6 weeks standard oral therapy
Sponsors
Sumitomo Pharma America, Inc.
Butler Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Mild to Moderate Insomnia
Exclusion criteria
* Any acute or chronic medical condition involving function of HPA axis (e.g., Cushing's or Addison's Disease, adrenal or pituitary gland disorders) * Currently taking, or unable to be free of, antidepressant, neuroleptic, anxiolytic, or thymoleptic drugs for at least 2 weeks preceding the DEX/CRH test (free of fluoxetine for at least 6 weeks) * Current use of psychotropic medication or medication (prescribed or over the counter) thought to affect HPA axis function or glucocorticoid synthesis/release (e.g., prednisone, anabolic steroids, DHEA, ketoconazole, metyrapone) * History of a significant adverse reaction to eszopiclone * Meets DSM-IV criteria for any Axis I psychiatric disorder, including substance abuse presently, or substance dependence within the past 6 months * Pregnancy, lactation, or unable/unwilling to use reliable methods of contraception during the study procedures * Limited mental competency and the inability to give informed, voluntary, written consent to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug) | post drug (6 weeks oral eszopiclone) | Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Open-label Eszopiclone Standard dosing of drug for 6 weeks for insomnia
eszopiclone : 6 weeks standard oral therapy | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Open-label Eszopiclone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Depressive Symptoms | 13.83 scores on a scale STANDARD_DEVIATION 8.24 |
| Insomnia Severity Index | 15.23 units on a scale STANDARD_DEVIATION 2.93 |
| plasma cortisol response to standardized dexamethasone/Corticotropin Releasing Hormone (DEX/CRH) | 146.23 nmol/L STANDARD_DEVIATION 161.85 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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).
Time frame: post drug (6 weeks oral eszopiclone)
Population: All subjects completed all study procedures
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-label Eszopiclone | Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug) | 108.98 nmol/L | Standard Deviation 129.19 |