Phase 3
N=150
TRIAD - Treatment of Insomnia and Depression
Sleep Initiation and Maintenance Disorders · Depression
Bottom Line
View on ClinicalTrials.gov: NCT00767624 ↗Enrolled (actual)
150
Serious AEs
3.3%
Results posted
Dec 2016
Primary outcome: Primary: Percent of Participants With Depression Remission — 36.0; 43.8 percentage of participants in arm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Antidepressant (Drug); Desensitization Therapy for Insomnia (Behavioral); Cognitive Behavioral Therapy for Insomnia (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Depression Remission |
36.0; 43.8 | — |
| SECONDARY Percentage of Participants in Insomnia Remission |
29; 54 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Meets criteria for Major Depressive Disorder
- Between 18 and 75 years of age and adequately fluent in English
- Meets criteria for an insomnia disorder
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00767624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.