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

Uma Rao

Status and phase: Unknown; Phase 4

Conditions: Depression

Treatments: Drug: Bupropion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00106197

DDTR B4-ARD

R01MH068391 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

1

Experimental group

Description:

Participants will receive bupropion in the sleep study

Treatment:

Drug: Bupropion