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Study 1 of 677 for search of: | received on or after 04/22/2009 |
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Sponsors and Collaborators: |
Butler Hospital Sepracor, Inc. |
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Information provided by: | Butler Hospital |
ClinicalTrials.gov Identifier: | NCT00889200 |
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.
Condition | Intervention | Phase |
---|---|---|
Insomnia |
Drug: eszopiclone |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Single Group Assignment |
Official Title: | Eszopiclone Treatment & Cortisol Response to HPA Axis Tests |
Enrollment: | 15 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | August 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Open-label Eszopiclone: Experimental
Standard dosing of drug for 6 weeks for insomnia
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Drug: eszopiclone
6 weeks standard oral therapy
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Rhode Island | |
Butler Hospital | |
Providence, Rhode Island, United States, 02906 |
Principal Investigator: | Linda Carpenter, MD | Butler Hospital |
Responsible Party: | Butler Hospital ( Linda Carpenter ) |
Study ID Numbers: | 0608-002 |
Study First Received: | April 23, 2009 |
Last Updated: | April 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00889200 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hydrocortisone Cortisol succinate Hydrocortisone acetate |