Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment Prediction in Adolescent and Adult Depression|
- Reduction in depressive symptoms [ Time Frame: Measured at Week 8 and Month 6 post-treatment ] [ Designated as safety issue: No ]
- Improvement in quality of life [ Time Frame: Measured at Week 8 and Month 6 post-treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Participants will receive bupropion in the sleep study
Participants will start with 150 mg daily. If no adverse symptoms, dosage will be increased to twice daily. Treatment will last for 8 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106197
|United States, Tennessee|
|Meharry Medical College|
|Nashville, Tennessee, United States, 37208|
|Principal Investigator:||Uma Rao, MD||Meharry Medical Collegey|