Journal of the American Academy of Child & Adolescent Psychiatry
ArticlesDouble-Blind, Placebo-Controlled Study of Amantadine Hydrochloride in the Treatment of Children With Autistic Disorder
Section snippets
Subjects
Forty-three subjects, aged 5 to 19 years, were recruited and enrolled in this multicenter study. Four subjects withdrew before baseline (three did not meet continued eligibility criteria and one required additional treatment for a preexisting condition); otherwise all patients completed the study. The study was conducted at six university medical centers following approval by the institutional review boards governing each site and was subject to informed consent (witnessed, written, and signed)
Parent-Rated ABC-CV Scores
The percentage of responders (reduction of at least 25% in subscale scores for the ABC-CV for irritability and/or hyperactivity at the end of treatment) in the group treated with amantadine hydrochloride was higher than in the placebo-treated group, 9/19 (47%) versus 7/19 (37%), respectively, but this difference was not statistically significant (p = .511). Exploratory analyses looking at the percentage of responders at 7, 14, 21, and 28 days showed that the response rate was slightly higher
DISCUSSION
There was no statistically significant difference in parent-rated categorical treatment responder rates. However, amantadine was associated with statistically significant improvements in certain investigator-rated ABC-CV subscales (e.g., Hyperactivity) and a trend (p < .1) toward improvements in outcome on the CGI scale. An unexpected finding was that, in contrast to recent clinical trials of other drugs in adults (McDougle et al., 1996, McDougle et al., 1998), treatment of children in this
REFERENCES (36)
- et al.
Methylphenidate treatment of hyperactive autistic children
J Am Acad Child Adolesc Psychiatry
(1988) - et al.
Case series: amantadine open-label treatment of impulsive and aggressive behavior in hospitalized children with developmental disabilities
J Am Acad Child Adolesc Psychiatry
(2001) - et al.
High levels of cerebrospinal fluid glutamate in Rett syndrome
Pediatr Neurol
(1996) Alternative medications for ADHD (letter)
J Am Acad Child Adolesc Psychiatry
(1997)- et al.
Physiological and pathophysiological roles of excitatory amino acids during central nervous system development
Brain Res Rev
(1990) Excitatory amino acids and neuropsychiatric disorders
Biol Psychiatry
(1989)Therapeutic potential of excitatory amino acid antagonists: channel blockers and 2,3-benzodiazepines
Trends Pharmacol Sci
(1993)- et al.
Neurochemical alterations in Rett syndrome
Dev Brain Res
(1993) - et al.
The Aberrant Behavior Checklist-Community: factor validity and effect of subject variables for adults in group homes
Am J Ment Retard
(1995) - et al.
The Aberrant Behavior Checklist
Am J Ment Defic
(1985)
Neuroanatomic observations of the brain in autism
Lamotrigine therapy for childhood autism: a randomized, double-blind, placebo-controlled trial
Neurology
Development of amino acid receptors in frontal cortex from girls with Rett syndrome
Ann Neurol
The effects of haloperidol on learning and behavior in autistic children
J Autism Dev Disord
Response to triiodothyronine and dextroamphetamine: a study of preschool, schizophrenic children
J Autism Child Schizophr
Levodopa and levoamphetamine: a crossover study in young schizophrenic children
Curr Ther Res Clin Exp
Amantadine: profile of use in the developmentally disabled
Differential Abilities Scale (DAS)
Cited by (0)
This study was funded by Cerebrus plc, Winnersh, U.K. The authors thank H. Eddine, J. Lainhart, D. Macarchick, A. Malekpour, and S. Smalley for their assistance.