TRIAD - Treatment of Insomnia and Depression
Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants
2 other identifiers
interventional
150
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2008
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2008
CompletedFirst Posted
Study publicly available on registry
October 7, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
December 5, 2016
CompletedDecember 5, 2016
October 1, 2016
6.5 years
October 3, 2008
August 5, 2016
October 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of Participants With Depression Remission
Depression remission was defined if both a and b below are satisfied 1. absence of both depressed mood and anhedonia for at least three consecutive weeks 2. no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks
16 weeks
Secondary Outcomes (1)
Percentage of Participants in Insomnia Remission
16 weeks
Study Arms (2)
antidepressant + desensitization
OTHERCombined antidepressant medication (determined by an algorithm) plus desensitization therapy
antidepressant + cognitive behavioral
OTHERCombined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
Interventions
Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Eligibility Criteria
You may qualify if:
- Meets criteria for Major Depressive Disorder
- Between 18 and 75 years of age and adequately fluent in English
- Meets criteria for an insomnia disorder
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Duke Universitycollaborator
- University of Pittsburghcollaborator
- University of Pennsylvaniacollaborator
Study Sites (3)
Stanford University School of Medicine
Stanford, California, 94305, United States
Duke University
Durham, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Related Publications (5)
Spina MA, Bei B, Rajaratnam SW, Krystal A, Edinger JD, Buysse DJ, Thase M, Manber R. 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. Sleep Med. 2024 Feb;114:137-144. doi: 10.1016/j.sleep.2023.12.014. Epub 2023 Dec 24.
PMID: 38183804DERIVEDEdinger JD, Smith ED, Buysse DJ, Thase M, Krystal AD, Wiskniewski S, Manber R. 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. J Clin Sleep Med. 2023 Jun 1;19(6):1111-1120. doi: 10.5664/jcsm.10514.
PMID: 36798983DERIVEDAsarnow LD, Bei B, Krystal A, Buysse DJ, Thase ME, Edinger JD, Manber R. Circadian Preference as a Moderator of Depression Outcome Following Cognitive Behavioral Therapy for Insomnia Plus Antidepressant Medications: A Report From the TRIAD Study. J Clin Sleep Med. 2019 Apr 15;15(4):573-580. doi: 10.5664/jcsm.7716.
PMID: 30952216DERIVEDBei B, Asarnow LD, Krystal A, Edinger JD, Buysse DJ, Manber R. Treating insomnia in depression: Insomnia related factors predict long-term depression trajectories. J Consult Clin Psychol. 2018 Mar;86(3):282-293. doi: 10.1037/ccp0000282.
PMID: 29504795DERIVEDManber R, Buysse DJ, Edinger J, Krystal A, Luther JF, Wisniewski SR, Trockel M, Kraemer HC, Thase ME. Efficacy of Cognitive-Behavioral Therapy for Insomnia Combined With Antidepressant Pharmacotherapy in Patients With Comorbid Depression and Insomnia: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Oct;77(10):e1316-e1323. doi: 10.4088/JCP.15m10244.
PMID: 27788313DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Our results do not inform clinical guidelines for any single antidepressant medication.
Results Point of Contact
- Title
- Rachel Manber, PhD
- Organization
- STANFORD UNIVERSITY
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Manber
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 3, 2008
First Posted
October 7, 2008
Study Start
December 1, 2008
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
December 5, 2016
Results First Posted
December 5, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share