TRIAD - Treatment of Insomnia and Depression
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ClinicalTrials.gov Identifier: NCT00767624 |
Recruitment Status
:
Completed
First Posted
: October 7, 2008
Results First Posted
: December 5, 2016
Last Update Posted
: December 5, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders Depression | Drug: Antidepressant Behavioral: Desensitization Therapy for Insomnia Behavioral: Cognitive Behavioral Therapy for Insomnia | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
antidepressant + desensitization
Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
|
Drug: Antidepressant
Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Behavioral: Desensitization Therapy for Insomnia
|
antidepressant + cognitive behavioral
Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
|
Drug: Antidepressant
Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Behavioral: Cognitive Behavioral Therapy for Insomnia
|
- Percent of Participants With Depression Remission [ Time Frame: 16 weeks ]
Depression remission was defined if both a and b below are satisfied
- absence of both depressed mood and anhedonia for at least three consecutive weeks
- no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks
- Percentage of Participants in Insomnia Remission [ Time Frame: 16 weeks ]Remission was defined as endpoint ISI<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767624
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States |
Principal Investigator: | Rachel Manber | Stanford University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Rachel Manber, Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT00767624 History of Changes |
Other Study ID Numbers: |
SU-08132008-1277 MH78924 |
First Posted: | October 7, 2008 Key Record Dates |
Results First Posted: | December 5, 2016 |
Last Update Posted: | December 5, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Additional relevant MeSH terms:
Depression Depressive Disorder Sleep Initiation and Maintenance Disorders Behavioral Symptoms Mood Disorders Mental Disorders |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Antidepressive Agents Psychotropic Drugs |