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NCT00025857 · ClinicalTrials.gov registry record
Brain Function in Mentally Ill Adolescents
A clinical trial of Healthy and Major Depressive Disorder, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 105
- Enrollment target
- 1
- Study location
NCT00025857 is a study of Healthy and Major Depressive Disorder that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 105 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00025857, a study of Healthy and Major Depressive Disorder, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 105 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to use brain imaging technology to examine the brain activity of adolescents with post-traumatic stress disorder (PTSD) and/or major depressive disorder (MDD) before and after treatment. Adults with PTSD or MDD exhibit abnormalities in the structure and function of certain parts of the brain. Although PTSD and MDD are psychiatric disorders that often emerge in childhood, the relationship between these disorders and brain structures has not been thoroughly studied in adolescents with the disorders. This study will use functional magnetic resonance imaging (fMRI) to study the parts of the brain that are involved in PTSD and MDD in adolescents. Adolescents with PTSD and/or MDD will be enrolled along with healthy adolescents with or without a history of abuse. Healthy adults will also be enrolled. Participants will be screened with a physical examination; blood tests; and interviews about mood, general degree of nervousness, and behavior. Adolescents and their parents will be interviewed separately and together. Following the interviews, participants will undergo psychological tests. Participants with PTSD and/or MDD will have two weekly sessions of talk therapy. Participants who continue to experience PTSD or MDD symptoms after the talk therapy may continue the talk therapy alone, begin treatment with fluoxetine (Prozac ) alone, or begin fluoxetine in addition to the talk therapy. Participants who take fluoxetine will have blood collected before treatment and 8 weeks after treatment has begun. If participants do not respond to the treatment, the treatment will be stopped and the participants will be offered another treatment. Participants who respond to treatment will continue treatment at NIH until a referral to an outside physician is made. Depending on the experiment in which they are enrolled, participants will undergo one or four MRI scans. Participants who will have four MRI scans will undergo the scans on separate days. During the
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2001-10-22 |
| Est. Completion | 2012-06-29 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00025857
The ClinicalTrials.gov registry entry for NCT00025857 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (84% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Healthy appearing as the primary indexed condition, and to 0 interventions.
NCT00025857 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00025857 about?
NCT00025857 is a clinical study titled "Brain Function in Mentally Ill Adolescents". The purpose of this study is to use brain imaging technology to examine the brain activity of adolescents with post-traumatic stress disorder (PTSD) and/or major depressive disorder (MDD) before and after treatment. Adults with PTSD or MDD exhibit abnormalities in the structure and function of cert...
What is the current status of trial NCT00025857?
This trial is currently completed. The enrollment target is 105 participants. The study started on 2001-10-22. Estimated completion is 2012-06-29.
What conditions does trial NCT00025857 study?
This clinical trial studies the following conditions: Healthy, Major Depressive Disorder, Posttraumatic Stress Disorder.
Who is sponsoring clinical trial NCT00025857?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00025857 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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