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Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults with Depression - Article


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Depression

Depression/depressive Disorders


Clinical Trial: Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults with Depression

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to determine whether there are age-related differences in the body systems controlling sleep and stress hormone patterns. This study will also determine whether the observed differences in sleep and hormone patterns between depressed adolescents and adults are associated with differences in their responses to antidepressant treatment.

Study hypothesis: 1) Depressed adolescents will reach rapid eye movement (REM) sleep faster and have higher cortisol levels in response to a single dose of bupropion compared with depressed adults who have taken single-dose bupropion. 2) Participants who take longer to reach REM sleep in response to single-dose bupropion will have better clinical response when treated with the drug compared with those who reach REM sleep faster in response to single-dose bupropion.

Condition Treatment or Intervention Phase
Depression
 Drug: Bupropion
Phase IV

MedlinePlus related topics:  Depression

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: Treatment Prediction in Adolescent and Adult Depression

Further Study Details: 
Primary Outcomes: Reduction in depressive symptoms
Secondary Outcomes: Improvement in quality of life
Expected Total Enrollment:  100

Study start: June 2004;  Expected completion: June 2009
Last follow-up: April 2009;  Data entry closure: April 2009

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 8 weeks. At study start, participants will be admitted to the medical center for a 2-night stay. On Night 1, participants will adapt to their surroundings. On the morning of Day 2, participants will be randomly assigned to receive a single dose of either the antidepressant bupropion or placebo. On Night 2, participants will have a catheter inserted into their bladders for urine collection and a test for cortisol, a stress hormone. Electrodes will be placed on participants' heads and bodies to measure the onset of REM sleep. On Day 3, participants will be discharged from the medical center and will continue to take bupropion or placebo twice daily for 8 weeks. After 8 weeks, participants will discontinue their assigned treatment and return to the medical center for another 2-night stay; the procedures performed during this stay will be similar to those conducted in the first. Night 1 will be an adaptation night. On Day 2, participants who previously received a placebo will receive bupropion treatment; those who previously received bupropion will receive a placebo. On Night 2, another sleep study and urine collection will occur. On Day 3, participants will complete depression self-report scales.

Eligibility

Ages Eligible for Study:  12 Years   -   50 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Diagnosis of major depressive disorder

Exclusion Criteria:

  • Current treatment with antidepressant drugs
  • Major medical illness
  • Diagnosis of anorexia nervosa or manic-depressive illness
  • Pregnancy

Location and Contact Information


Texas
      University of Texas Southwestern Medical Center, Dallas,  Texas,  75390-9101,  United States; Recruiting
Jacqueline Rivers  214-645-8176    jacqueline.rivers@utsouthwestern.edu 
Uma Rao, MD  214-645-8172    uma.rao@utsouthwestern.edu 
Uma Rao, MD,  Principal Investigator

Study chairs or principal investigators

Uma Rao, MD,  Principal Investigator,  University of Texas Southwestern Medical Center   

More Information

Publications

Ott GE, Rao U, Nuccio I, Lin KM, Poland RE. Effect of bupropion-SR on REM sleep: relationship to antidepressant response. Psychopharmacology (Berl). 2002 Dec;165(1):29-36. Epub 2002 Nov 6.

Study ID Numbers:  RO1-MH68391
Record last reviewed:  March 2005
Last Updated:  March 21, 2005
Record first received:  March 21, 2005
ClinicalTrials.gov Identifier:  NCT00106197
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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July 25, 2008



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