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
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Meharry Medical College:

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: 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.

  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
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 ClinicalTrials.gov identifier: NCT00106197

Locations
United States, Tennessee
Meharry Medical College
Nashville, Tennessee, United States, 37208
Sponsors and Collaborators
Uma Rao
Investigators
Principal Investigator: Uma Rao, MD Meharry Medical Collegey
  More Information

No publications provided

Responsible Party: Uma Rao, Principal investigator, Meharry Medical College
ClinicalTrials.gov Identifier: NCT00106197     History of Changes
Other Study ID Numbers: R01 MH068391, DDTR B4-ARD, R01MH068391
Study First Received: March 21, 2005
Last Updated: August 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Meharry Medical College:
Sleep, REM
Antidepressant
Adolescent
Cortisol

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Bupropion
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents, Second-Generation
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 02, 2014