Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration

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City:		Hershey
State:		Pennsylvania
Zip Code:		17033

Conditions:		Insomnia
Purpose:		The purpose of this study is to evaluate the effect of a 3 month medication trial of Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic insomnia.
Study Summary:		Participants with chronic insomnia associated with objective short sleep duration will be recruited to participate in a 3 month clinical trial on the efficacy of trazodone versus CBT. The primary outcome measure will be objective sleep duration as measured by both actigraphy and polysomnography. The secondary outcome measure will be subjective severity of sleep disturbance and subjective sleep duration.
Criteria:		Inclusion Criteria: - Chronic insomnia with duration of more than 1 year - Objective short sleep duration (< 6 hours) - BMI < 39 - Ages 30-60 - Men & Women Exclusion Criteria: - Major Mental Illness - Substance Abuse/Dependence - Sleep Apnea - Periodic Limb Movement Disorder - Shift Work or circadian disorders - Diabetes - Chronic Renal Failure, Hepatic Insufficiency, Chronic Heart Failure - Current Use of hypnotics or sleep inducing sedative antidepressants
NCT ID:		NCT01348542
Primary Contact:		Principal Investigator Alexandros N Vgontzas, MD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Carrie A Criley, BA, RPSGT Phone: 717 531-4123 Email: ccriley@psu.edu
Backup Contact:		Email: jfernandezmendoza@hmc.psu.edu Julio Fernandez-Mendoza, PhD Phone: 717 531-0003 ext. 285570
Location Contact:		Hershey, Pennsylvania 17033 United States Carrie A Criley, BA, RPSGT Phone: 717-531-4123 Email: ccriley@psu.edu Site Status: Recruiting

Data Source:		ClinicalTrials.gov
Date Processed:		May 18, 2013
Modifications to this listing:		Only selected fields are shown, please use the link below to view all information about this clinical trial.
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