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
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