Clinical trial NCT00106197: Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression
Official title: Treatment Prediction in Adolescent and Adult Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Depression
Keywords: Sleep, REM
Antidepressant
Adolescent
Cortisol
Lead sponsor: Meharry Medical College
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-03-22
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of major depressive disorder and/or dysthymic disorder

Exclusion Criteria:

* Current treatment with antidepressant drugs
* Major medical illness
* Diagnosis of anorexia nervosa or manic-depressive illness
* Pregnancy

Primary outcomes:
measure: Reduction in depressive symptoms
timeFrame: Measured at Week 8 and Month 6 post-treatment
Secondary outcomes:
measure: Improvement in quality of life
timeFrame: Measured at Week 8 and Month 6 post-treatment
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
Study officials:
affiliation: Meharry Medical Collegey
name: Uma Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: