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Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00106197
  Purpose

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.


Condition Intervention Phase
Depression
Drug: Bupropion
Phase IV

MedlinePlus related topics: Antidepressants Depression
Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Bupropion hydrochloride Bupropion
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Treatment Prediction in Adolescent and Adult Depression

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Reduction in depressive symptoms [ Time Frame: Measured at Week 8 and Month 6 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in quality of life [ Time Frame: Measured at Week 8 and Month 6 post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2004
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive bupropion in the sleep study
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.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106197

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9101
Contact: Megan Kuhn-McKearin     214-648-5250     TeenHealth@utsouthwestern.edu    
Principal Investigator: Uma Rao, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Uma Rao, MD University of Texas Southwestern Medical Center
  More Information

Publications:
Responsible Party: University of Texas Southwestern Medical Center at Dallas ( Uma Rao )
Study ID Numbers: R01 MH68391, DDTR B4-ARD
Study First Received: March 21, 2005
Last Updated: August 18, 2008
ClinicalTrials.gov Identifier: NCT00106197  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Sleep, REM
Antidepressant
Adolescent
Cortisol

Study placed in the following topic categories:
Hydrocortisone
Depression
Cortisol succinate
Mental Disorders
Bupropion
Mood Disorders
Hydrocortisone acetate
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 30, 2009