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

Depression Clinical Trial

Official title:

Treatment Prediction in Adolescent and Adult Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00106197
• Other study ID #: R01MH068391
• Secondary ID: DDTR B4-ARDR01MH
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 21, 2005
• Last updated: August 29, 2013
• Start date: June 2004
• Est. completion date: March 2014

Study information

• Verified date: August 2013
• Source: Meharry Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Meharry Medical College	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Uma Rao	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in depressive symptoms		Measured at Week 8 and Month 6 post-treatment	No
Secondary	Improvement in quality of life		Measured at Week 8 and Month 6 post-treatment	No