TRIAD - Treatment of Insomnia and Depression - Full Text View

Sponsors and Collaborators:	Stanford University Duke University University of Pittsburgh University of Pennsylvania
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00767624

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: escitalopram Drug: sertraline Drug: desvenlafaxine Behavioral: Insomnia Therapy	Phase II Phase III

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Sertraline hydrochloride Sertraline Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Desvenlafaxine Succinate Desvenlafaxine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants

Further study details as provided by Stanford University:

Primary Outcome Measures:

Rate of depression remission

Secondary Outcome Measures:

Rate of insomnia remission

Estimated Enrollment:	320
Study Start Date:	December 2008

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:

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.

Contacts and Locations

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

Locations

United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Katherine L Taylor, MPH 650-723-2641 klilytay@stanford.edu
Principal Investigator: Rachel Manber
United States, North Carolina
Duke University	Recruiting
Durham, North Carolina, United States
Contact: Faye Knauss, PsyD 919-681-0935 faye.knauss@duke.edu
Principal Investigator: Jack Edinger
United States, Pennsylvania
University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Susan Berman, MEd 412-246-5731 bermansr@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

Study ID Numbers:	SU-08132008-1277, MH78924
Study First Received:	October 3, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767624
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Depression
Sleep Disorders
Dyssomnias
Depressive Disorder
Citalopram
Serotonin

Behavioral Symptoms
Sleep Disorders, Intrinsic
Mental Disorders
O-desmethylvenlafaxine
Mood Disorders
Sertraline
Dexetimide

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009