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TRIAD - Treatment of Insomnia and Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00767624
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborators:
Duke University
University of Pittsburgh
University of Pennsylvania
Information provided by (Responsible Party):
Rachel Manber, Stanford University

Study Description
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Brief Summary:
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 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

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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percent of Participants With Depression Remission [ Time Frame: 16 weeks ]

    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 :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Rachel Manber Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rachel Manber, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00767624    
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:
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Sleep Initiation and Maintenance Disorders
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs