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| Descriptive Information Fields | |||||
| Brief Title † | Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression | ||||
| Official Title † | 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 nights in the sleep lab and a week later two more nights in the lab. Participants will be able to leave during the day. Upon completion of 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 † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Reduction in depressive symptoms [ Time Frame: Measured at Week 8 and Month 6 post-treatment ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Improvement in quality of life [ Time Frame: Measured at Week 8 and Month 6 post-treatment ] [ Designated as safety issue: No ] | ||||
| Condition † | Depression | ||||
| Intervention † | Drug: Bupropion | ||||
| MEDLINE PMIDs | 12474115 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 100 | ||||
| Start Date † | June 2004 | ||||
| Completion Date | March 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00106197 | ||||
| Organization ID | R01 MH68391 | ||||
| Secondary IDs †† | DDTR B4-ARD | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2008 | ||||
| First Received Date † | March 21, 2005 | ||||
| Last Updated Date | February 12, 2008 | ||||
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