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Adolescent Medial Temporal Lobe Function in Health and Illness
Sponsor study identifier
Secondary identifiers
observational
105
1 country
1
Study Start
October 22, 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
June 29, 2012
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 29, 2012
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2001
Date type not reportedThis date has not been verified as actual or estimated.
October 26, 2001
Actual (reported)October 29, 2001
Actual (reported)June 29, 2012
Date type not reportedThis date has not been verified as actual or estimated.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
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.
Birmaher 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.
Monique Ernst, M.D.
National Institute of Mental Health (NIMH)
105 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2001
First Posted
October 29, 2001
Study Start
October 22, 2001
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Blair 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.
Study Completion
June 29, 2012
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
December 3, 2019
Record last verified: 2012-06-29
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Source: ClinicalTrials.gov.
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