Depression (Pediatric) Research Study
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Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes
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This study uses functional magnetic resonance imaging (fMRI) to learn how the brain functions in adolescents receiving fluoxetine (Prozac) or cognitive behavioral therapy (CBT) for anxiety or depression in children/adolescents.
All participants will receive interviews to assess how they are doing in general, including his or her general mood, degree of nervousness and behavior. Each participant and one of his or her parents will be interviewed separately and together. All those enrolled in the study will have a physical examination. They will undergo tests involving problem-solving and memory and perform tasks that involve looking at pictures, remembering things, testing reaction times, and making simple choices.
Participants with anxiety or depression will first meet with a psychiatrist or psychologist for two weekly sessions of talk therapy. Those who remain anxious or depressed after these 2 weeks will have the 3 options based on their choice: 1) treatment with fluoxetine daily for 8 weeks 2) cognitive-behavioral therapy (a talk therapy) once a week for 8 weeks 3) a random assignment (50% chance) to either placebo or fluoxetine for 8 weeks. All participants will be seen approximately weekly for 8 weeks by a doctor to talk and complete verbal and written exercises. Blood samples will be drawn for laboratory tests before drug treatment and after it ends.
Those who have not improved by the end of the study will be offered other treatment for 1 to 3 months, and the clinicians will help with finding subsequent aftercare. Those who improve with treatment will continue therapy at NIH until an outside physician is able to assume responsibility for monitoring medication.
To find out if you qualify or for more information, please call (301) 402-8225 or email us at kidswithworries@mail.nih.gov.
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Protocol Information |
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