Brain Function in Mentally Ill Adolescents
Adolescent Medial Temporal Lobe Function in Health and Illness
2 other identifiers
observational
105
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2001
Longer than P75 for all trials
1 active site
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
October 22, 2001
CompletedFirst Submitted
Initial submission to the registry
October 26, 2001
CompletedFirst Posted
Study publicly available on registry
October 29, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2012
CompletedDecember 3, 2019
June 29, 2012
October 26, 2001
November 30, 2019
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
- SUBJECTS WITH MAJOR DEPRESSION:
- Diagnosis: Current diagnosis of MDD.
- Clinical Impairment: CGAS less than 60.
- SUBJECTS WITH PTSD:
- Diagnosis: current diagnosis of PTSD.
- Clinical Impairment: CGAS of less than 60.
- SUBJECTS WITH HISTORY OF TRAUMA:
- 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.
You may not qualify if:
- 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.
- Pregnancy.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Bernstein DP, Fink L, Handelsman L, Foote J, Lovejoy M, Wenzel K, Sapareto E, Ruggiero J. Initial reliability and validity of a new retrospective measure of child abuse and neglect. Am J Psychiatry. 1994 Aug;151(8):1132-6. doi: 10.1176/ajp.151.8.1132.
PMID: 8037246BACKGROUNDBirmaher B, Dahl RE, Ryan ND, Rabinovich H, Ambrosini P, al-Shabbout M, Novacenko H, Nelson B, Puig-Antich J. The dexamethasone suppression test in adolescent outpatients with major depressive disorder. Am J Psychiatry. 1992 Aug;149(8):1040-5. doi: 10.1176/ajp.149.8.1040.
PMID: 1636803BACKGROUNDBlair RJ, Morris JS, Frith CD, Perrett DI, Dolan RJ. Dissociable neural responses to facial expressions of sadness and anger. Brain. 1999 May;122 ( Pt 5):883-93. doi: 10.1093/brain/122.5.883.
PMID: 10355673BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monique Ernst, M.D.
National Institute of Mental Health (NIMH)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 26, 2001
First Posted
October 29, 2001
Study Start
October 22, 2001
Study Completion
June 29, 2012
Last Updated
December 3, 2019
Record last verified: 2012-06-29