TRIAD - Treatment of Insomnia and Depression

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 depressive disorder and insomnia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborators: Duke University; University of Pennsylvania; University of Pittsburgh
• Treatments: Antidepressive Agents

Criteria

Inclusion Criteria:

1. Meets criteria for Major Depressive Disorder

2. Between 18 and 75 years of age and adequately fluent in English

3. Meets criteria for an insomnia disorder

Exclusion Criteria:

1. Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.

2. People for whom the antidepressant medication(s) provided in the study is not indicated

3. People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.

4. People with uncontrolled medical conditions.

5. People with moderate or severe sleep disorders other than insomnia

6. Individuals on a fixed night shift or rotating work schedule that requires a night shift.

7. Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.