NCT00767624

TRIAD - Treatment of Insomnia and Depression

Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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 for insomnia will be determined by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or desensitization psychotherapy for insomnia. The study physician will select an initial antidepressant medication from a list of three possible medications . If that medication is not helpful, another medication may be tried after 8 weeks or in the event of severe side effects.

Conditions

• Sleep Initiation and Maintenance Disorders
• Depression

Interventions

Type	Name	Description
DRUG	Antidepressant	Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
BEHAVIORAL	Desensitization Therapy for Insomnia
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia

Timeline

• Start date: 2008-12-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2008-10-07
• Last updated: 2016-12-05
• Results posted: 2016-12-05

Locations

3 sites across 1 country: United States