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| Tracking Information | |||||
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| First Received Date ICMJE | March 21, 2005 | ||||
| Last Updated Date | September 4, 2009 | ||||
| Start Date ICMJE | June 2004 | ||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reduction in depressive symptoms [ Time Frame: Measured at Week 8 and Month 6 post-treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Reduction in depressive symptoms | ||||
| Change History | Complete list of historical versions of study NCT00106197 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Improvement in quality of life [ Time Frame: Measured at Week 8 and Month 6 post-treatment ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Improvement in quality of life | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression | ||||
| Official Title ICMJE | Treatment Prediction in Adolescent and Adult Depression | ||||
| Brief Summary | This study will determine whether there are age-related differences in the body systems controlling sleep and stress hormone patterns. This study will also determine whether the differences in sleep and hormone patterns between depressed adolescents and adults are associated with differences in their response to antidepressant treatment. |
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| Detailed Description | Adolescent depression is a serious public health concern that may lead to functional disability and death. The problems associated with the condition may continue into adulthood; therefore, early identification and effective treatment of adolescent depression is critical. Studies indicate that depressed adolescents experience greater variations in sleep and hormone patterns than depressed adults. These variations may influence responses to antidepressant treatment. This study will examine the mechanisms underlying developmental differences in sleep and hormone patterns to develop a strategy for identifying adolescents and adults who could benefit from antidepressant treatment. This study will last approximately 10 weeks. At study start, participants will wear an activity monitor on their wrist and keep track of their nightly sleep schedule to establish baseline measures. This will continue for 2 weeks. During the second week of wearing this watch the participant will be asked to come in for a sleep study. This study will consist of two initial nights in the sleep lab and then two more nights in the lab a week later. Participants will be able to leave during the day. Upon completing the sleep assessment, participants will receive bupropion twice daily for 8 weeks. Upon completion of this 8-week treatment, participants will be interviewed to assess the effectiveness of the treatment. One follow-up meeting will occur 6 months post-treatment. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Depression | ||||
| Intervention ICMJE | Drug: Bupropion | ||||
| Study Arms / Comparison Groups | Experimental: Participants will receive bupropion in the sleep study | ||||
| Publications * | Ott GE, Rao U, Nuccio I, Lin KM, Poland RE. Effect of bupropion-SR on REM sleep: relationship to antidepressant response. Psychopharmacology (Berl). 2002 Dec;165(1):29-36. Epub 2002 Nov 6. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | March 2011 | ||||
| Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00106197 | ||||
| Responsible Party | Uma Rao, University of Texas Southwestern Medical Center at Dallas | ||||
| Study ID Numbers ICMJE | R01 MH068391, DDTR B4-ARD | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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