Skip to content

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

Treatment Prediction in Adolescent and Adult Depression

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00106197
Enrollment
130
Registered
2005-03-22
Start date
2004-06-30
Completion date
2014-03-31
Last updated
2013-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Sleep, REM, Antidepressant, Adolescent, Cortisol

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.

Interventions

DRUGBupropion

Participants will start with 150 mg daily. If no adverse symptoms, dosage will be increased to twice daily. Treatment will last for 8 weeks.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Uma Rao
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frame
Reduction in depressive symptomsMeasured at Week 8 and Month 6 post-treatment

Secondary

MeasureTime frame
Improvement in quality of lifeMeasured at Week 8 and Month 6 post-treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026