Phase 4
N=12
Eszopiclone Treatment & Cortisol Responsivity
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00889200 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug) — 108.98 nmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- eszopiclone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Butler Hospital
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug) |
108.98 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00889200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.