Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia



Status:Completed
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:30 - 60
Updated:1/6/2019
Start Date:April 2011
End Date:June 1, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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.

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
We found this trial at
1
site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
Principal Investigator: Alexandros N Vgontzas, MD
Phone: 717-531-4123
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mi
from
Hershey, PA
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