TRIAD - Treatment of Insomnia and Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2013 by Stanford University.
Recruitment status was  Active, not recruiting
Duke University
University of Pittsburgh
University of Pennsylvania
Information provided by (Responsible Party):
Stanford University Identifier:
First received: October 3, 2008
Last updated: November 27, 2013
Last verified: November 2013
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
Drug: Antidepressant
Behavioral: Desensitization Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:
  • Rate of depression remission [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of Insomnia remission [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: December 2008
Estimated Primary Completion Date: April 2014 (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.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Meets criteria for Major Depressive Disorder
  2. Between 18 and 75 years of age and adequately fluent in English
  3. Meets criteria for an insomnia disorder

Exclusion Criteria:

  1. Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
  2. People for whom the antidepressant medication(s) provided in the study is not indicated
  3. People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
  4. People with uncontrolled medical conditions.
  5. People with moderate or severe sleep disorders other than insomnia
  6. Individuals on a fixed night shift or rotating work schedule that requires a night shift.
  7. Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.
  Contacts and Locations
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Please refer to this study by its identifier: 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
Sponsors and Collaborators
Stanford University
Duke University
University of Pittsburgh
University of Pennsylvania
Principal Investigator: Rachel Manber Stanford University
  More Information

Responsible Party: Stanford University Identifier: NCT00767624     History of Changes
Other Study ID Numbers: SU-08132008-1277  MH78924 
Study First Received: October 3, 2008
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mental Disorders
Mood Disorders
Nervous System Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Antidepressive Agents
Psychotropic Drugs processed this record on May 26, 2016