Status:
COMPLETED
TRIAD - Treatment of Insomnia and Depression
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Duke University
University of Pittsburgh
Conditions:
Sleep Initiation and Maintenance Disorders
Depression
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depress...
Detailed Description
Participants with major depressive disorder and insomnia who meet all study criteria will receive state-of-the-art antidepressant medications and one of two insomnia therapies. The specific therapy fo...
Eligibility Criteria
Inclusion
- Meets criteria for Major Depressive Disorder
- Between 18 and 75 years of age and adequately fluent in English
- Meets criteria for an insomnia disorder
Exclusion
- Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
- People for whom the antidepressant medication(s) provided in the study is not indicated
- People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
- People with uncontrolled medical conditions.
- People with moderate or severe sleep disorders other than insomnia
- Individuals on a fixed night shift or rotating work schedule that requires a night shift.
- Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00767624
Start Date
December 1 2008
End Date
June 1 2015
Last Update
December 5 2016
Active Locations (3)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
Duke University
Durham, North Carolina, United States
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States