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TRIAD - Treatment of Insomnia and Depression

This study has been completed.
Sponsor:
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
  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
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:
  • Percent of Participants With Depression Remission [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Percentage of Participants in Insomnia Remission [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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

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

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
Health Authority: United States: Institutional Review Board
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 December 09, 2016