TRIAD - Treatment of Insomnia and Depression

October 10, 2016 updated by: Rachel Manber, Stanford University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
OTHER: antidepressant + cognitive behavioral
Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
Behavioral: Cognitive Behavioral Therapy for Insomnia
Drug: Antidepressant
Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

University of Pennsylvania
University of Pittsburgh
Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (ESTIMATE)

October 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-08132008-1277
  • MH78924

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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