Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106197
Status:
UNKNOWN
Last Update Posted:
2013-08-30
First Post:
2005-03-21
Brief Title:
Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression
Sponsor:
Uma Rao
Organization:
Meharry Medical College
Study Overview
Official Title:
Treatment Prediction in Adolescent and Adult Depression
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH068391 | NIH | None | httpsreporternihgovquickSearchR01MH068391 |
| DDTR B4-ARD | None | None | None |