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

Tracking Information

First Received Date ^ICMJE

March 21, 2005

Last Updated Date

September 4, 2009

Start Date ^ICMJE

June 2004

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Reduction in depressive symptoms

Change History

Complete list of historical versions of study NCT00106197 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Improvement in quality of life

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Treatment Prediction in Adolescent and Adult Depression

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.

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Bupropion

Study Arms / Comparison Groups

Experimental: Participants will receive bupropion in the sleep study

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: John Weir, Ph.D.

214-648-5258

john.weir@utsouthwestern.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00106197

Responsible Party

Uma Rao, University of Texas Southwestern Medical Center at Dallas

Study ID Numbers ^ICMJE

R01 MH068391, DDTR B4-ARD

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Uma Rao, MD

University of Texas Southwestern Medical Center

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP