Phase 3
Completed N=150
TRIAD - Treatment of Insomnia and Depression
Sleep Initiation and Maintenance Disorders · Depression
Source: ClinicalTrials.gov NCT00767624 ↗
Enrolled (actual)
150
Serious AEs
3.3%
Results posted
Dec 2016
Primary outcomePrimary: Percent of Participants With Depression Remission — 36.0; 43.8 percentage of participants in arm
◆ Published Evidence
Highly cited
152citations · ~15 / year
Efficacy of Cognitive-Behavioral Therapy for Insomnia Combined With Antidepressant Pharmacotherapy in Patients With Comorbid Depression and Insomnia: A Randomized Controlled Trial.
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.
Linked Publications (5)
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Efficacy of Cognitive-Behavioral Therapy for Insomnia Combined With Antidepressant Pharmacotherapy in Patients With Comorbid Depression and Insomnia: A Randomized Controlled Trial.
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Treating insomnia in depression: Insomnia related factors predict long-term depression trajectories.
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Circadian Preference as a Moderator of Depression Outcome Following Cognitive Behavioral Therapy for Insomnia Plus Antidepressant Medications: A Report From the TRIAD Study.
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Objective sleep duration and response to combined pharmacotherapy and cognitive behavioral insomnia therapy among patients with comorbid depression and insomnia: a report from the TRIAD study.
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Cognitive behavioural therapy for insomnia reduces actigraphy and diary measured sleep discrepancy for individuals with comorbid insomnia and major depressive disorder: A report from the TRIAD study.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.