View Clinical Trial (Medical Research Study)
Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants
| City: |
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Stanford |
| State: |
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California |
| Zip Code: |
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94305 |
| Conditions: |
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Sleep Initiation and Maintenance Disorders - Depression |
| Purpose: |
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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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| Study Summary: |
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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.
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| Criteria: |
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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.
5. People with uncontrolled medical conditions. 6. People with moderate or severe sleep
disorders other than insomnia 7. Individuals on a fixed night shift or rotating work
schedule that requires a night shift.
8. Patients with a current principal diagnosis of a psychiatric disorder that
necessitates treatment that is not offered in the study.
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| NCT ID: |
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NCT00767624 |
| Primary Contact: |
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Principal Investigator
Rachel Manber
Stanford University
Rachel A Wells, BA
Phone: (650) 723-2641
Email: rawells@stanford.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Stanford, California 94305
United States
Rachel A Wells, BA
Phone: 650-723-2641
Email: rawells@stanford.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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