Durham, North Carolina


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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00767624


Primary Contact:

Principal Investigator
Rachel Manber
Stanford University

Haddas A Elisha, BSc
Phone: (650) 723-2641
Email: helisha@stanford.edu


Backup Contact:

N/A


Location Contact:

Durham, North Carolina
United States

Pamela Smith
Phone: 919-681-0934
Email: pamela.smith@duke.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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