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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106197
Recruitment Status : Unknown
Verified August 2013 by Uma Rao, Meharry Medical College.
Recruitment status was:  Active, not recruiting
First Posted : March 22, 2005
Last Update Posted : August 30, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Uma Rao, Meharry Medical College

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Bupropion Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Prediction in Adolescent and Adult Depression
Study Start Date : June 2004
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: 1
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.

Primary Outcome Measures :
  1. Reduction in depressive symptoms [ Time Frame: Measured at Week 8 and Month 6 post-treatment ]

Secondary Outcome Measures :
  1. Improvement in quality of life [ Time Frame: Measured at Week 8 and Month 6 post-treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00106197

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United States, Tennessee
Meharry Medical College
Nashville, Tennessee, United States, 37208
Sponsors and Collaborators
Uma Rao
National Institute of Mental Health (NIMH)
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Principal Investigator: Uma Rao, MD Meharry Medical Collegey

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Responsible Party: Uma Rao, Principal investigator, Meharry Medical College Identifier: NCT00106197     History of Changes
Other Study ID Numbers: R01MH068391 ( U.S. NIH Grant/Contract )
R01MH068391 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2005    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013
Keywords provided by Uma Rao, Meharry Medical College:
Sleep, REM
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors