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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

October 3, 2008
October 10, 2016
December 2008
June 2015   (final data collection date for primary outcome measure)
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
Rate of depression remission
Complete list of historical versions of study NCT00767624 on ClinicalTrials.gov Archive Site
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.
Rate of Insomnia remission
Not Provided
Not Provided
 
TRIAD - Treatment of Insomnia and Depression
Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Sleep Initiation and Maintenance Disorders
  • Depression
  • Drug: Antidepressant
    Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
  • Behavioral: Desensitization Therapy for Insomnia
  • Behavioral: Cognitive Behavioral Therapy for Insomnia
  • antidepressant + desensitization
    Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
    Interventions:
    • Drug: Antidepressant
    • Behavioral: Desensitization Therapy for Insomnia
  • antidepressant + cognitive behavioral
    Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
    Interventions:
    • Drug: Antidepressant
    • Behavioral: Cognitive Behavioral Therapy for Insomnia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00767624
SU-08132008-1277, MH78924
Yes
No
Not Provided
Rachel Manber, Stanford University
Stanford University
  • Duke University
  • University of Pittsburgh
  • University of Pennsylvania
Principal Investigator: Rachel Manber Stanford University
Stanford University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP