This is to be a double-blind placebo-controlled crossover study of methylphenidate and fenfluramine in 30 mentally retarded children with hyperactivity (Attention Deficit Hyperactivity Disorder). Methylphenidate will be given in standardized doses of 0.4 mg/kg/day, whereas three doses of fenfluramine (1.0, 1.5, 2.0 mg/kg/day) will be compared. Each drug condition will be administered for two weeks. All children will be assessed for changes on standardized parent and teacher behavior rating scales, tests of cognitive performance, an independent academic task, systematic behavior observations, heart rate and blood pressure, and an extensive listing of side effects. The data will be analyzed to (1) evaluate the clinical (behavioral) effects of each drug, (2) compare drug effects on learning performance, (3) determine if one of the fenfluramine doses is superior for clinical and/or cognitive outcome, and (4) determine whether certain compelling subject characteristics are helpful in predicting drug response.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH044122-04
Application #
3383580
Study Section
Treatment Development and Assessment Research Review Committee (TDA)
Project Start
1989-02-01
Project End
1994-07-31
Budget Start
1992-08-01
Budget End
1993-07-31
Support Year
4
Fiscal Year
1992
Total Cost
Indirect Cost
Name
Ohio State University
Department
Type
Schools of Medicine
DUNS #
098987217
City
Columbus
State
OH
Country
United States
Zip Code
43210
Brown, Elaine C; Aman, Michael G; Lecavalier, Luc (2004) Empirical classification of behavioral and psychiatric problems in children and adolescents with mental retardation. Am J Ment Retard 109:445-55
Aman, Michael G; Buican, Brett; Arnold, L Eugene (2003) Methylphenidate treatment in children with borderline IQ and mental retardation: analysis of three aggregated studies. J Child Adolesc Psychopharmacol 13:29-40
Aman, Michael G; Armstrong, Sharon; Buican, Brett et al. (2002) Four-year follow-up of children with low intelligence and ADHD: a replication. Res Dev Disabil 23:119-34
Brown, Elaine C; Aman, Michael G; Havercamp, Susan M (2002) Factor analysis and norms for parent ratings on the Aberrant Behavior Checklist-Community for young people in special education. Res Dev Disabil 23:45-60
Shultz, J M; Aman, M G; Rojahn, J (1998) Psychometric evaluation of a measure of cognitive decline in elderly people with mental retardation. Res Dev Disabil 19:63-71
Aman, M G; Kern, R A; Osborne, P et al. (1997) Fenfluramine and methylphenidate in children with mental retardation and borderline IQ: clinical effects. Am J Ment Retard 101:521-34
Sarphare, G; Aman, M G (1996) Parent- and self-ratings of anxiety in children with mental retardation: agreement levels and test-retest reliability. Res Dev Disabil 17:27-39
Aman, M G; Pejeau, C; Osborne, P et al. (1996) Four-year follow-up of children with low intelligence and ADHD. Res Dev Disabil 17:417-32
Aman, M G; Tasse, M J; Rojahn, J et al. (1996) The Nisonger CBRF: a child behavior rating form for children with developmental disabilities. Res Dev Disabil 17:41-57
Tasse, M J; Aman, M G; Hammer, D et al. (1996) The Nisonger Child Behavior Rating Form: age and gender effects and norms. Res Dev Disabil 17:59-75

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