NCT00106197

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for phase_4 depression

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_4 depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2005

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 30, 2013

Status Verified

August 1, 2013

Enrollment Period

9.8 years

First QC Date

March 21, 2005

Last Update Submit

August 29, 2013

Conditions

Depression

Keywords

Sleep, REMAntidepressantAdolescentCortisol

Outcome Measures

Primary Outcomes (1)

  • Reduction in depressive symptoms

    Measured at Week 8 and Month 6 post-treatment

Secondary Outcomes (1)

  • Improvement in quality of life

    Measured at Week 8 and Month 6 post-treatment

Study Arms (1)

1

EXPERIMENTAL

Participants will receive bupropion in the sleep study

Drug: Bupropion

Interventions

BupropionDRUG

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

1

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of major depressive disorder and/or dysthymic disorder

You may not qualify if:

  • Current treatment with antidepressant drugs
  • Major medical illness
  • Diagnosis of anorexia nervosa or manic-depressive illness
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Uma Rao, MD

    Meharry Medical Collegey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 21, 2005

First Posted

March 22, 2005

Study Start

June 1, 2004

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 30, 2013

Record last verified: 2013-08

Locations

US(1)