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Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia

NCT01348542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-02-25

Study results available
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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.

Conditions

Interventions

DRUG

Trazodone

50 mg once a day, for 3 months

BEHAVIORAL

Cognitive Behavioral Therapy

The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Alexandros N Vgontzas, MD · Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2018-06-01
Completion
2018-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01348542 on ClinicalTrials.gov