TRIAD - Treatment of Insomnia and Depression
This study has been completed.
Sponsor:
Stanford University
Collaborators:
Duke University
University of Pittsburgh
University of Pennsylvania
Information provided by (Responsible Party):
Rachel Manber, Stanford University
ClinicalTrials.gov Identifier:
NCT00767624
First received: October 3, 2008
Last updated: October 10, 2016
Last verified: October 2016
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Purpose
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.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| Enrollment: | 150 |
| Study Start Date: | December 2008 |
| Study Completion Date: | June 2015 |
| Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767624
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767624
Locations
| 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 | |
Sponsors and Collaborators
Stanford University
Duke University
University of Pittsburgh
University of Pennsylvania
Investigators
| Principal Investigator: | Rachel Manber | Stanford University |
More Information
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 |
| Study First Received: | October 3, 2008 |
| Results First Received: | August 5, 2016 |
| Last Updated: | October 10, 2016 |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on May 22, 2017