TRIAD - Treatment of Insomnia and Depression

Depression Clinical Trial

Official title:

Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00767624
• Other study ID #: SU-08132008-1277
• Secondary ID: MH78924
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: October 3, 2008
• Last updated: November 27, 2013
• Start date: December 2008

Study information

• Verified date: November 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Antidepressant
Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance

Behavioral:
• Desensitization Therapy for Insomnia

• Cognitive Behavioral Therapy for Insomnia

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Stanford University School of Medicine	Stanford	California

Sponsors (4)

Lead Sponsor	Collaborator
Stanford University	Duke University, University of Pennsylvania, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of depression remission			No
Secondary	Rate of Insomnia remission			No