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Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Insomnia

Intervention: Trazodone (Drug); Cognitive Behavioral Therapy (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Milton S. Hershey Medical Center

Official(s) and/or principal investigator(s):
Alexandros N Vgontzas, MD, Principal Investigator, Affiliation: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Overall contact:
Carrie A Criley, BA, RPSGT, Phone: 717 531-4123, Email: ccriley@psu.edu

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from Baseline in objective sleep duration at 9 months

Secondary outcome: Change from Baseline in Subjective Severity of Sleep Disturbance & Subjective Sleep Duration at 9 months

Detailed description: 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.

Eligibility

Minimum age: 30 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Carrie A Criley, BA, RPSGT, Phone: 717 531-4123, Email: ccriley@psu.edu

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Carrie A Criley, BA, RPSGT, Phone: 717-531-4123, Email: ccriley@psu.edu
Julio Fernandez-Mendoza, PhD, Phone: 717 531-0003, Ext: 285570, Email: jfernandezmendoza@hmc.psu.edu
Alexandros N Vgontzas, MD, Principal Investigator
Additional Information

Related publications:

Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Basta M, Fernández-Mendoza J, Bixler EO. Insomnia with short sleep duration and mortality: the Penn State cohort. Sleep. 2010 Sep;33(9):1159-64.

Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Bixler EO. Insomnia with objective short sleep duration is associated with type 2 diabetes: A population-based study. Diabetes Care. 2009 Nov;32(11):1980-5. doi: 10.2337/dc09-0284. Epub 2009 Jul 29.

Vgontzas AN, Liao D, Bixler EO, Chrousos GP, Vela-Bueno A. Insomnia with objective short sleep duration is associated with a high risk for hypertension. Sleep. 2009 Apr;32(4):491-7.

Vgontzas AN, Bixler EO, Lin HM, Prolo P, Mastorakos G, Vela-Bueno A, Kales A, Chrousos GP. Chronic insomnia is associated with nyctohemeral activation of the hypothalamic-pituitary-adrenal axis: clinical implications. J Clin Endocrinol Metab. 2001 Aug;86(8):3787-94.

Fernandez-Mendoza J, Calhoun S, Bixler EO, Pejovic S, Karataraki M, Liao D, Vela-Bueno A, Ramos-Platon MJ, Sauder KA, Vgontzas AN. Insomnia with objective short sleep duration is associated with deficits in neuropsychological performance: a general population study. Sleep. 2010 Apr;33(4):459-65.

Fernandez-Mendoza J, Calhoun SL, Bixler EO, Karataraki M, Liao D, Vela-Bueno A, Jose Ramos-Platon M, Sauder KA, Basta M, Vgontzas AN. Sleep misperception and chronic insomnia in the general population: role of objective sleep duration and psychological profiles. Psychosom Med. 2011 Jan;73(1):88-97. doi: 10.1097/PSY.0b013e3181fe365a. Epub 2010 Oct 26.

Starting date: April 2011
Last updated: April 13, 2015

Page last updated: August 23, 2015

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