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

Primary Purpose

Depression

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Sponsored by
Uma Rao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Sleep, REM, Antidepressant, Adolescent, Cortisol

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Meharry Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Participants will receive bupropion in the sleep study

Outcomes

Primary Outcome Measures

Reduction in depressive symptoms

Secondary Outcome Measures

Improvement in quality of life

Full Information

First Posted
March 21, 2005
Last Updated
August 29, 2013
Sponsor
Uma Rao
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00106197
Brief Title
Hormone and Sleep Response to Antidepressant Treatment in Adolescents and Adults With Depression
Official Title
Treatment Prediction in Adolescent and Adult Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Uma Rao
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Sleep, REM, Antidepressant, Adolescent, Cortisol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive bupropion in the sleep study
Intervention Type
Drug
Intervention Name(s)
Bupropion
Intervention Description
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 Measure Information:
Title
Reduction in depressive symptoms
Time Frame
Measured at Week 8 and Month 6 post-treatment
Secondary Outcome Measure Information:
Title
Improvement in quality of life
Time Frame
Measured at Week 8 and Month 6 post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uma Rao, MD
Organizational Affiliation
Meharry Medical Collegey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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