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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Uma Rao, Meharry Medical College.
Recruitment status was:  Active, not recruiting
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Uma Rao, Meharry Medical College Identifier:
First received: March 21, 2005
Last updated: August 29, 2013
Last verified: August 2013
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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Prediction in Adolescent and Adult Depression

Resource links provided by NLM:

Further study details as provided by Uma Rao, Meharry Medical College:

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

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

Estimated Enrollment: 130
Study Start Date: June 2004
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00106197

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

Responsible Party: Uma Rao, Principal investigator, Meharry Medical College Identifier: NCT00106197     History of Changes
Other Study ID Numbers: R01MH068391 ( U.S. NIH Grant/Contract )
Study First Received: March 21, 2005
Last Updated: August 29, 2013

Keywords provided by Uma Rao, Meharry Medical College:
Sleep, REM

Additional relevant MeSH terms:
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 processed this record on September 21, 2017