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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Uma Rao, Meharry Medical College
ClinicalTrials.gov Identifier:
NCT00106197
First received: March 21, 2005
Last updated: August 29, 2013
Last verified: August 2013

March 21, 2005
August 29, 2013
June 2004
March 2014   (final data collection date for primary outcome measure)
Reduction in depressive symptoms [ Time Frame: Measured at Week 8 and Month 6 post-treatment ] [ Designated as safety issue: No ]
Reduction in depressive symptoms
Complete list of historical versions of study NCT00106197 on ClinicalTrials.gov Archive Site
Improvement in quality of life [ Time Frame: Measured at Week 8 and Month 6 post-treatment ] [ Designated as safety issue: No ]
Improvement in quality of life
Not Provided
Not Provided
 
Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression
Treatment Prediction in Adolescent and Adult Depression

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
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.
Experimental: 1
Participants will receive bupropion in the sleep study
Intervention: Drug: Bupropion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
12 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00106197
R01 MH068391, DDTR B4-ARD, R01MH068391
Yes
Uma Rao, Meharry Medical College
Uma Rao
National Institute of Mental Health (NIMH)
Principal Investigator: Uma Rao, MD Meharry Medical Collegey
Meharry Medical College
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP