TRIAD - Treatment of Insomnia and Depression

Stanford University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sleep Initiation and Maintenance Disorders; Depression

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia; Drug: Antidepressant; Behavioral: Desensitization Therapy for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT00767624

SU-08132008-1277

MH78924

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

antidepressant + desensitization

Other group

Description:

Combined antidepressant medication (determined by an algorithm) plus desensitization therapy

Treatment:

Drug: Antidepressant

Behavioral: Desensitization Therapy for Insomnia

antidepressant + cognitive behavioral

Other group

Description:

Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy

Treatment:

Drug: Antidepressant

Behavioral: Cognitive Behavioral Therapy for Insomnia