TRIAD - Treatment of Insomnia and Depression

Completed · Phase 2/Phase 3

Conditions studied: Sleep Initiation and Maintenance Disorders, Depression

In brief

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 depressive disorder and insomnia.

Key facts

Study ID

NCT00767624

Run by

Stanford University

People needed

150

Starts

2008-12-01

Expected to finish

2015-06-01

Last updated by the study team

2016-12-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets criteria for Major Depressive Disorder
• Between 18 and 75 years of age and adequately fluent in English
• Meets criteria for an insomnia disorder

You may not qualify if…

• 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.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• Duke University — Durham, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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