Trial Outcomes & Findings for Eszopiclone Treatment & Cortisol Responsivity (NCT NCT00889200)

NCT ID: NCT00889200

Last Updated: 2017-09-08

Results Overview

Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: post drug (6 weeks oral eszopiclone)
• Results posted on: 2017-09-08

Participant Flow

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.

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.

Participant milestones

Measure	Open-label Eszopiclone Standard daily dosing of 3 mg drug nightly for 6 weeks for insomnia eszopiclone : 6 weeks standard oral therapy
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eszopiclone Treatment & Cortisol Responsivity

Baseline characteristics by cohort

Measure	Open-label Eszopiclone n=12 Participants Standard dosing of drug for 6 weeks for insomnia eszopiclone : 6 weeks standard oral therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Depressive Symptoms	13.83 scores on a scale STANDARD_DEVIATION 8.24 • n=5 Participants
plasma cortisol response to standardized dexamethasone/Corticotropin Releasing Hormone (DEX/CRH)	146.23 nmol/L STANDARD_DEVIATION 161.85 • n=5 Participants
Insomnia Severity Index	15.23 units on a scale STANDARD_DEVIATION 2.93 • n=5 Participants

PRIMARY outcome

Timeframe: post drug (6 weeks oral eszopiclone)

Population: All subjects completed all study procedures

Cortisol reponse to the DEX/CRH test post-treatment is the same as measured and calculated at baseline =delta(CORT).

Outcome measures

Measure	Open-label Eszopiclone n=12 paired t-test cortisol reactivity After Standard dosing of drug for 6 weeks for insomnia, Dex/CRH test was repeated to measure cortisol reactivity with the same neuroendocrine test
Cortisol Response to the Dex/CRH Test Post-treatment (6 Weeks Oral Drug)	108.98 nmol/L Standard Deviation 129.19

Adverse Events

Open-label Eszopiclone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Linda Carpenter, MD

Butler Hospital

Phone: 401 455 6349

Email: Linda_Carpenter_MD@Brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place