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Completed

NCT Number: NCT00767624

TRIAD - Treatment of Insomnia and Depression

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Stanford University School of Medicine, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets criteria for Major Depressive Disorder
  • Between 18 and 75 years of age and adequately fluent in English
  • Meets criteria for an insomnia disorder

Exclusion criteria

  • Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
  • People for whom the antidepressant medication(s) provided in the study is not indicated
  • People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
  • People with uncontrolled medical conditions.
  • People with moderate or severe sleep disorders other than insomnia
  • Individuals on a fixed night shift or rotating work schedule that requires a night shift.
  • Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.

Treatment and study plan

Antidepressant

Drug

Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Desensitization Therapy for Insomnia

Behavioral

Cognitive Behavioral Therapy for Insomnia

Behavioral

Primary outcomes

  1. Percent of Participants With Depression Remission

    Time frame: 16 weeks

    Depression remission was defined if both a and b below are satisfied

    • absence of both depressed mood and anhedonia for at least three consecutive weeks
    • no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Duke University
  • University of Pennsylvania
  • University of Pittsburgh

Registry information

Official study title

Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Oct 7, 2008
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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