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Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity.
Arch Gen Psychiatry. 2005 Nov; 62(11):1266-74.AG

Abstract

CONTEXT

Hyperactivity and inattention are common symptoms in children with autistic disorder and related pervasive developmental disorders, but studies of stimulants in these conditions have been inconclusive.

OBJECTIVES

To determine the efficacy and safety of methylphenidate hydrochloride in children with pervasive developmental disorders and hyperactivity.

DESIGN

Double-blind, placebo-controlled, crossover trial followed by open-label continuation.

SETTING

Five academic outpatient clinics.

PARTICIPANTS

Seventy-two drug-free children, aged 5 to 14 years, with pervasive developmental disorders accompanied by moderate to severe hyperactivity.

INTERVENTIONS

Prior to randomization, subjects entered a 1-week test-dose phase in which each subject received placebo for 1 day followed by increasing doses of methylphenidate (low, medium, and high doses) that were each given for 2 days. The low, medium, and high doses of methylphenidate hydrochloride were based on weight, and they ranged from 7.5 mg/d to 50.0 mg/d in divided doses. Subjects who tolerated the test dose (n = 66) were assigned to receive placebo for 1 week and then 3 methylphenidate doses in random order during a double-blind, crossover phase. Children responding to methylphenidate then entered 8 weeks of open-label treatment at the individually determined best dose.

MAIN OUTCOME MEASURES

The primary outcome measure was the teacher-rated hyperactivity subscale of the Aberrant Behavior Checklist. Response was defined as "much improved" or "very much improved" on the Clinical Global Impressions Improvement item coupled with considerable reductions in the parent-rated and/or teacher-rated Aberrant Behavior Checklist hyperactivity subscale score.

RESULTS

Methylphenidate was superior to placebo on the primary outcome measure, with effect sizes ranging from 0.20 to 0.54 depending on dose and rater. Thirty-five (49%) of 72 enrolled subjects were classified as methylphenidate responders. Adverse effects led to the discontinuation of study medication in 13 (18%) of 72 subjects.

CONCLUSIONS

Methylphenidate was often efficacious in treating hyperactivity associated with pervasive developmental disorders, but the magnitude of response was less than that seen in typically developing children with attention-deficit/hyperactivity disorder. Adverse effects were more frequent.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

16275814

Citation

Research Units on Pediatric Psychopharmacology Autism Network. "Randomized, Controlled, Crossover Trial of Methylphenidate in Pervasive Developmental Disorders With Hyperactivity." Archives of General Psychiatry, vol. 62, no. 11, 2005, pp. 1266-74.
Research Units on Pediatric Psychopharmacology Autism Network. Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Arch Gen Psychiatry. 2005;62(11):1266-74.
Research Units on Pediatric Psychopharmacology Autism Network. (2005). Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Archives of General Psychiatry, 62(11), 1266-74.
Research Units on Pediatric Psychopharmacology Autism Network. Randomized, Controlled, Crossover Trial of Methylphenidate in Pervasive Developmental Disorders With Hyperactivity. Arch Gen Psychiatry. 2005;62(11):1266-74. PubMed PMID: 16275814.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. A1 - ,, PY - 2005/11/9/pubmed PY - 2005/12/13/medline PY - 2005/11/9/entrez SP - 1266 EP - 74 JF - Archives of general psychiatry JO - Arch Gen Psychiatry VL - 62 IS - 11 N2 - CONTEXT: Hyperactivity and inattention are common symptoms in children with autistic disorder and related pervasive developmental disorders, but studies of stimulants in these conditions have been inconclusive. OBJECTIVES: To determine the efficacy and safety of methylphenidate hydrochloride in children with pervasive developmental disorders and hyperactivity. DESIGN: Double-blind, placebo-controlled, crossover trial followed by open-label continuation. SETTING: Five academic outpatient clinics. PARTICIPANTS: Seventy-two drug-free children, aged 5 to 14 years, with pervasive developmental disorders accompanied by moderate to severe hyperactivity. INTERVENTIONS: Prior to randomization, subjects entered a 1-week test-dose phase in which each subject received placebo for 1 day followed by increasing doses of methylphenidate (low, medium, and high doses) that were each given for 2 days. The low, medium, and high doses of methylphenidate hydrochloride were based on weight, and they ranged from 7.5 mg/d to 50.0 mg/d in divided doses. Subjects who tolerated the test dose (n = 66) were assigned to receive placebo for 1 week and then 3 methylphenidate doses in random order during a double-blind, crossover phase. Children responding to methylphenidate then entered 8 weeks of open-label treatment at the individually determined best dose. MAIN OUTCOME MEASURES: The primary outcome measure was the teacher-rated hyperactivity subscale of the Aberrant Behavior Checklist. Response was defined as "much improved" or "very much improved" on the Clinical Global Impressions Improvement item coupled with considerable reductions in the parent-rated and/or teacher-rated Aberrant Behavior Checklist hyperactivity subscale score. RESULTS: Methylphenidate was superior to placebo on the primary outcome measure, with effect sizes ranging from 0.20 to 0.54 depending on dose and rater. Thirty-five (49%) of 72 enrolled subjects were classified as methylphenidate responders. Adverse effects led to the discontinuation of study medication in 13 (18%) of 72 subjects. CONCLUSIONS: Methylphenidate was often efficacious in treating hyperactivity associated with pervasive developmental disorders, but the magnitude of response was less than that seen in typically developing children with attention-deficit/hyperactivity disorder. Adverse effects were more frequent. SN - 0003-990X UR - https://www.unboundmedicine.com/medline/citation/16275814/Randomized_controlled_crossover_trial_of_methylphenidate_in_pervasive_developmental_disorders_with_hyperactivity_ L2 - https://jamanetwork.com/journals/jamapsychiatry/fullarticle/10.1001/archpsyc.62.11.1266 DB - PRIME DP - Unbound Medicine ER -