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TRIAD - Treatment of Insomnia and Depression

This study is currently recruiting participants.
Verified April 2013 by Stanford University
Sponsor:
Collaborators:
Duke University
University of Pittsburgh
University of Pennsylvania
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00767624
First received: October 3, 2008
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  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
Primary Purpose: Treatment
Official Title: Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants

Resource links provided by NLM:

U.S. FDA Resources

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: 320
Study Start Date: December 2008
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
antidepressant + desensitization Drug: Antidepressant
Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance
Behavioral: Desensitization Therapy for Insomnia
antidepressant + cognitive behavioral 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
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.

5. People with uncontrolled medical conditions. 6. People with moderate or severe sleep disorders other than insomnia 7. Individuals on a fixed night shift or rotating work schedule that requires a night shift.

8. Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767624

Contacts
Contact: Rocio A Mendoza, BSc (650) 723-2641 rocio@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Rachel A Wells, BA     650-723-2641     rawells@stanford.edu    
Principal Investigator: Rachel Manber            
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States
Contact: Meg Lineberger, PhD     919-668-3267     meg.lineberger@duke.edu    
Principal Investigator: Jack Edinger            
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Crystal Spotts, MEd     412-246-5764     spottscr@upmc.edu    
Principal Investigator: Daniel Buysse            
Sponsors and Collaborators
Stanford University
Duke University
University of Pittsburgh
University of Pennsylvania
Investigators
Principal Investigator: Rachel Manber Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00767624     History of Changes
Other Study ID Numbers: SU-08132008-1277, MH78924
Study First Received: October 3, 2008
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Disorders
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013