This trial is active, not recruiting.

Condition depression
Treatment bupropion
Phase phase 4
Sponsor Uma Rao
Collaborator National Institute of Mental Health (NIMH)
Start date June 2004
End date March 2014
Trial size 130 participants
Trial identifier NCT00106197, DDTR B4-ARD, R01 MH068391, R01MH068391


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.

Primary Outcomes

Reduction in depressive symptoms
time frame: Measured at Week 8 and Month 6 post-treatment

Secondary Outcomes

Improvement in quality of life
time frame: Measured at Week 8 and Month 6 post-treatment

Eligibility Criteria

Male or female participants from 12 years up to 50 years old.

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

Additional Information

Official title Treatment Prediction in Adolescent and Adult Depression
Principal investigator Uma Rao, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Meharry Medical College.