Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

This study is currently recruiting participants.
Verified October 2013 by Milton S. Hershey Medical Center
Sponsor:
Information provided by (Responsible Party):
Alexandros Vgontzas, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01348542
First received: April 20, 2011
Last updated: October 7, 2013
Last verified: October 2013
  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.


Condition Intervention
Insomnia
Drug: Trazodone
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Trazodone vs. Cognitive Behavioral Therapy in Patients With Chronic Insomnia Associated With Objective Short Sleep Duration

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Change from Baseline in objective sleep duration at 9 months [ Time Frame: Baseline, 3 months & 9 months ] [ Designated as safety issue: No ]
    Polysomnography & Actigraphy will be used to measure sleep duration at baseline, post treatment (3 months) and follow-up (9 months).


Secondary Outcome Measures:
  • Change from Baseline in Subjective Severity of Sleep Disturbance & Subjective Sleep Duration at 9 months [ Time Frame: Baseline, 3 months & 9 months ] [ Designated as safety issue: No ]
    Sleep Diary and subjective questionnaires will be used to measure severity of sleep disturbance and subjective sleep duration at baseline, post treatment (3 months) and follow-up (9 months).


Estimated Enrollment: 24
Study Start Date: April 2011
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trazodone Drug: Trazodone
50 mg once a day, for 3 months
Active Comparator: Cognitive Behavioral Therapy Behavioral: Cognitive Behavioral Therapy
The CBT Protocol is implemented over a period of 12 weeks, with consultations held on a weekly basis.

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

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348542

Contacts
Contact: Carrie A Criley, BA, RPSGT 717 531-4123 ccriley@psu.edu
Contact: Julio Fernandez-Mendoza, PhD 717 531-0003 ext 285570 jfernandezmendoza@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Carrie A Criley, BA, RPSGT    717-531-4123    ccriley@psu.edu   
Contact: Julio Fernandez-Mendoza, PhD    717 531-0003 ext 285570    jfernandezmendoza@hmc.psu.edu   
Principal Investigator: Alexandros N Vgontzas, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Alexandros N Vgontzas, MD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  More Information

Publications:

Responsible Party: Alexandros Vgontzas, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01348542     History of Changes
Other Study ID Numbers: 35933
Study First Received: April 20, 2011
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Chronic Insomnia
Short Sleep Duration
Trazodone
Cognitive Behavioral Therapy
Efficacy

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on April 15, 2014