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Brain Function in Mentally Ill Adolescents
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), October 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00025857

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® (Registered Trademark)) 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 MRI, participants will complete tasks on a computer. Saliva samples will be collected before and after the scans. Participants with PTSD and/or MDD will collect their saliva one or two days before the MRI scan.

Posttraumatic Stress Disorder
Major Depressive Disorder

MedlinePlus related topics: Anxiety Depression MRI Scans Nuclear Scans Post-Traumatic Stress Disorder
U.S. FDA Resources
Study Type: Observational
Official Title: Adolescent Medial Temporal Lobe Function in Health and Illness

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 400
Study Start Date: October 2001
Detailed Description:

Adults with post-traumatic stress disorder (PTSD) or major depressive disorder (MDD) exhibit abnormalities in the structure and function of the amygdala and hippocampus (temporal lobe), as well as in the prefrontal cortex (PFC) and striatum (four brain structures underlying the emotional processing and reward systems). However, while these psychiatric disorders often emerge in childhood, the integrity of these neural structures has been minimally studied in psychiatrically impaired children and adolescents. In the current proposal, functional MRI (fMRI) will be used to evaluate the amygdala, hippocampus, PFC and striatum in (1) psychiatrically healthy adolescents; (2) adolescents with trauma history and PTSD or anxiety symptoms; (3) adolescents with trauma history, symptoms of depression and either PTSD or anxiety symptoms; and (4) adolescents with only major depressive or PTSD/anxiety symptoms; (5) adolescents with trauma and no trauma related symptoms. The proposed study is conducted in three separate experiments.

At this stage of the protocol, we completed experiment 1, and a pilot study to help guide experiments 2 and 3. In Experiment 1, we determined whether a fear conditioning paradigm elicited amygdala activity in healthy adolescents. The pilot study examined test-retest reliability of the fMRI signal in healthy adolescents and adults.

In Experiment 2, we will examine the functioning of the amygdala, hippocampus, PFC and striatum in healthy adolescents and those with the psychiatric conditions described above. During image acquisition, four cognitive tasks, targeting these regions, will be used: 1) a social interaction task, 2) an inhibition task (the Stop task or the antisaccade task), 3) an emotional rating/explicit memory task and 4) a probe detection task. One hundred twenty five participants (25 in five groups) will be recruited in experiment 2.

Experiment 3 will address the same question as in experiment 2 in relation to treatment response. In other words, in contrast to experiment 2, patients will be studied prior and after treatment of the psychopathology associated with their traumatic experience. The sample will include 125 patients (25 in each of the 4 groups) and 25 controls.


Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

All subjects 7-18 (adolescents).

Consent: can give consent/assent.

IQ: all subjects will have IQ greater than 70.

Subjects currently on antidepressants or benzodiazepines medication.

Subjects suffering from ADHD and currently on stimulants.


Diagnosis: Current diagnosis of MDD.

Clinical Impairment: CGAS less than 60.


Diagnosis: current diagnosis of PTSD.

Clinical Impairment: CGAS of less than 60.


Trauma (i.e., sexual or physical abuse, exposure to an accident, etc.) will be defined according to the KSADS, the Child Trauma Questionnaire, the Life Events Survey and the history of adoption.


Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign material in eye).

Any medical condition that increases risk for fluoxetine treatment for patients with MDD/PTSD.


Participants suffering from acute psychosis or suicidal ideation; current abuse/dependency to alcohol or drugs.

Currently in an abusive situation at home.

Weight that is 15% more or less than ideal body weight for sex and height.

Current tobacco use.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025857

Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

United States, Delaware
University of Delaware Recruiting
Newark, Delaware, United States
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Study ID Numbers: 020007, 02-M-0007
Study First Received: October 26, 2001
Last Updated: November 22, 2008
ClinicalTrials.gov Identifier: NCT00025857  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Magnetic Resonance Imaging
Normal Volunteers
Physical/Sexual Abuse History
Post-Traumatic Stress Disorder
Healthy Volunteer
Normal Control

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Mood Disorders
Stress Disorders, Post-Traumatic
Depressive Disorder, Major
Depressive Disorder
Stress Disorders, Traumatic
Behavioral Symptoms

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 30, 2009