Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00106197|
Recruitment Status : Unknown
Verified August 2013 by Uma Rao, Meharry Medical College.
Recruitment status was: Active, not recruiting
First Posted : March 22, 2005
Last Update Posted : August 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Bupropion||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment Prediction in Adolescent and Adult Depression|
|Study Start Date :||June 2004|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2014|
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.
- Reduction in depressive symptoms [ Time Frame: Measured at Week 8 and Month 6 post-treatment ]
- Improvement in quality of life [ Time Frame: Measured at Week 8 and Month 6 post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106197
|United States, Tennessee|
|Meharry Medical College|
|Nashville, Tennessee, United States, 37208|
|Principal Investigator:||Uma Rao, MD||Meharry Medical Collegey|