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TRIAD - Treatment of Insomnia and Depression

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep Initiation and Maintenance Disorders; Depression

Intervention: Antidepressant (Drug); Desensitization Therapy for Insomnia (Behavioral); Cognitive Behavioral Therapy for Insomnia (Behavioral)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Rachel Manber, Principal Investigator, Affiliation: Stanford University

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.

Clinical Details

Official title: Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rate of depression remission

Secondary outcome: Rate of Insomnia remission

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Stanford University School of Medicine, Stanford, California 94305, United States

Duke University, Durham, North Carolina, United States

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Additional Information

Starting date: December 2008
Last updated: November 27, 2013

Page last updated: August 23, 2015

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