Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Bupropion |
Phase 4 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 130 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive bupropion in the sleep study
|
Drug: Bupropion
Participants will start with 150 mg daily. If no adverse symptoms, dosage will be increased to twice daily. Treatment will last for 8 weeks.
|
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| Ages Eligible for Study: | 12 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Corinne Davis, MPH | 615-327-6589 | davisc@mmc.edu |
| United States, Tennessee | |
| Meharry Medical College | Recruiting |
| Nashville, Tennessee, United States, 37208 | |
| Contact: Corinne Davis, MPH 615-327-6589 davisc@mmc.edu | |
| Principal Investigator: Uma Rao, MD | |
| Principal Investigator: | Uma Rao, MD | Meharry Medical Collegey |
More Information
No publications provided
| Responsible Party: | Uma Rao, Principal investigator, Meharry Medical College |
| ClinicalTrials.gov Identifier: | NCT00106197 History of Changes |
| Other Study ID Numbers: | R01 MH068391, DDTR B4-ARD, R01MH068391 |
| Study First Received: | March 21, 2005 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Meharry Medical College:
|
Sleep, REM Antidepressant Adolescent Cortisol |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Antidepressive Agents Bupropion Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Antidepressive Agents, Second-Generation Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013