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

NCT ID: NCT00106197

Last Updated: 2013-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Depression

Keywords

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Sleep, REM Antidepressant Adolescent Cortisol

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Participants will receive bupropion in the sleep study

Group Type EXPERIMENTAL

Bupropion

Intervention Type DRUG

Participants will start with 150 mg daily. If no adverse symptoms, dosage will be increased to twice daily. Treatment will last for 8 weeks.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Uma Rao

OTHER

Sponsor Role lead

Responsible Party

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Uma Rao

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Uma Rao, MD

Role: PRINCIPAL_INVESTIGATOR

Meharry Medical Collegey

Locations

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Meharry Medical College

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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DDTR B4-ARD

Identifier Type: -

Identifier Source: secondary_id

R01MH068391

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH068391

Identifier Type: NIH

Identifier Source: org_study_id

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