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Sponsors and Collaborators: |
University of California, Irvine University of California, San Diego |
Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00581009 |
This study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Sleep deprivation and chronobiological augmentation may offer a rapid and sustained antidepressant response in mood disorder patients treated with medication, sleep deprivation, bright light therapy and sleep phase advance compared with medication only. The chronobiological treatment is rapid, non-invasive and has few side effects and could be of significant clinical benefit.
Condition | Intervention | Phase |
Major Depressive Disorder Bipolar Disorder |
Other: chronobiological augmentation Drug: sertraline, lithium Radiation: one night of sleep deprivation and two FDG PET scans |
Phase I Phase II |
MedlinePlus related topics: | Antidepressants Bipolar Disorder Depression Nuclear Scans |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients |
Estimated Enrollment: | 180 |
Study Start Date: | March 2001 |
Estimated Study Completion Date: | January 2018 |
Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
chronobiological augmentation group
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Other: chronobiological augmentation
Sleep deprivation for one night, Chronobiological augmentation consists of partial sleep phase advance for three nights and Light therapy for two hours for three days
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2: Experimental
medication only group
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Drug: sertraline, lithium
Antidepressant, Subjects will be started on a serotonin specific reuptake inhibitor (SSRI), sertraline 100 mg (50mg hs x 2) daily or other SSRI's such as Paxil 20 mg or Prozac 20 mg daily and continue treatment for seven weeks. Mood stabilizer, subjects will be treated with lithium 450 mg twice a day or another mood stabilizer such as depakote or valproate and continue treatment for seven weeks. |
MDD Mechanism: Experimental |
Radiation: one night of sleep deprivation and two FDG PET scans
MDD Mechanism Only depressed subjects will have two FDG PET scans consisting of a baseline FDG PET scan and a sleep deprived FDG PET scan. One night of regular sleep,one night of sleep deprivation and one night of recovery sleep for a total of four nights at a sleep laboratory facility.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Inclusion criteria include:
Non-English speaking subjects will be excluded since scales for measuring depression have not been validated in languages other than English.
Exclusion Criteria:
Exclusion criteria include:
Contact: Joseph C Wu, M.D. | 949-824-7867 | jcwu@uci.edu |
United States, California | |||||
University of California, Irvine | Recruiting | ||||
Irvine, California, United States, 92697 | |||||
Contact: Joseph C Wu, M.D. 949-824-7867 jcwu@uci.edu | |||||
Sub-Investigator: William E Bunney, Jr., M.D. | |||||
Sub-Investigator: Steven Potkin, M.D. | |||||
Sub-Investigator: Jody Rawles, M.D. | |||||
Sub-Investigator: Charles Nguyen, M.D. | |||||
Sub-Investigator: Marquis Vawter, Ph.D. | |||||
Sub-Investigator: Marcel Hungs, M.D. | |||||
University of California, San Diego | Recruiting | ||||
La Jolla, California, United States, 92093 - 0603 | |||||
Contact: John R Kelsoe, M.D. 858-534-5927 jkelsoe@ucsd.edu | |||||
Principal Investigator: John R Kelsoe, M.D. |
University of California, Irvine |
University of California, San Diego |
Study Chair: | Barry F Chaitin, M.D. | University of California, Irvine |
Responsible Party: | University of California, Irvine ( Joseph C. Wu, M. D. ,Associate Professor, Psychiatry, UCI-SOM, Clinical Director, Brain Imaging Center ) |
Study ID Numbers: | HS#2001-1616 |
First Received: | December 19, 2007 |
Last Updated: | June 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00581009 |
Health Authority: | United States: Institutional Review Board |
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