Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment Prediction in Adolescent and Adult Depression

Conditions
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Depression

Intervention / Treatment
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* Drug: Bupropion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive bupropion in the sleep study | Drug: Bupropion<br>* Participants will start with 150 mg daily. If no adverse symptoms, dosage will be increased to twice daily. Treatment will last for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in depressive symptoms |  | Measured at Week 8 and Month 6 post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life |  | Measured at Week 8 and Month 6 post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, REM, Antidepressant, Adolescent, Cortisol