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Home > "B" Clinical Trials Conditions > Brain Function in Mentally Ill Adolescents  Brain Function in Mentally Ill Adolescents
Brain Function in Mentally Ill Adolescents
For Condition: Healthy,Posttraumatic Stress Disorder,Major Depressive Disorder
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: Adults with post-traumatic stress disorder (PTSD) or major depressive disorder (MDD) exhibit abnormalities in the structure and function of the amygdala and hippocampus. However, while these psychiatric disorders often emerge in childhood, the integrity of these neural structures have been minimally studied in psychiatrically impaired children and adolescents. In current proposal, function MRI (fMRI) will be used to evaluate the amygdala and the hippocampus in (1) psychiatrically healthy adolescents; (2) adolescents with abuse history and PTSD or anxiety symptoms; (3)adolescents with abuse history, symptoms of depression and either PTSD or anxiety symptoms; and (4) adolescents with only major depressive symptoms; (5) adolescents with abuse and no trauma related symptoms. The proposed study will be conducted in three separate experiments/phases. In Experiment 1/ Phase 1, we will determine whether the fear conditioning paradigm elicits amygdala activity in healthy adolescents. For the pilot phase of Experiment 2/3, we will conduct a pilot study in healthy adolescents and adults to examine the effects on the fMRI signal from repeat testing with the tasks described below for Experiment 2 and 3. In Experiment 2/Phase 2, the functioning of the amygdala and hippocampus will be examined in healthy adolescents and those with the psychiatric conditions described above. During image acquisition, 2 cognitive tasks will be used to recruit medial temporal lobe activation: an emotional rating/explicit memory task and a probe detection task will engage both the amygdala and the hippocampus. 125 participants will be recruited for this study, 25 patients in each of the five groups. An additional 25 healthy adolescents will participate in Experiment 1 and 12 healthy adolescents, as well as 12 adults, will be subjects in the pilot phase for Experiment 2/3. In Experiment 3/Phase 3, individually tailored open treatment will be provided to patients with either PTSD or MDD, and responsivity will be assessed. Following 8 weeks of treatment, all participants will return and fMRI will be used again to examine amygdalar-hippocampal functioning as participants perform the same tasks as in Experiment 2. Thus, irrespective of treatment, Experiment 3 will examine whether the effects found in Experiment 2 diminish in patients whose symptoms resolve. These results will provide preliminary data on the degree to which neurophysiological correlates of psychopathology in Experiment 2 represent state as opposed to trait markers for psychopathology.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: All subjects 9-17 (adolescents). Pubertal Status: Puberty. Consent: can give consent/assent. IQ: all subjects will have IQ greater than 70. 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 ABUSE: Following Heim et al.(2000), physical and/or sexual abuse must have occurred for at least 1 year and the frequency must be at least once a month. EXCLUSION CRITERIA: 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. Currently in an abusive situation at home. Current use of any psychoactive substance, a current suicidal ideation, current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy. Current diagnosis of Tourette's Disorder, obsessive-compulsive disorder, or conduct disorder. Weight that is 15% more or less than ideal body weight for sex and height. Current use tobacco.
Total Enrollment: 400
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 020007; 02-M-0007
Study Start Date: October 22, 2001
Record last reviewed: December 30, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025857
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Brain Function in Mentally Ill Adolescents
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