A placebo-controlled study of lofexidine in the treatment of children with tic disorders and attention deficit hyperactivity disorder.

Full Abstract

This study evaluated the efficacy and safety of Lofexidine in treating children with tic disorders and attention deficit hyperactivity disorder (ADHD). Subjects from a specialty tic disorders clinic were randomly assigned to receive 8 weeks of treatment with lofexidine or placebo under double-blind conditions. Follow-up visits occurred every 2 weeks for safety monitoring and dose adjustment. Fourty-four medication-free subjects (41 boys and three girls; mean age of 10.4 years) with ADHD, combined type, and a tic disorder participated. After 8 weeks of treatment, lofexidine was associated with a mean improvement of 41% in the total score on the teacher-rated ADHD Rating Scale compared to 7% improvement for placebo. Eleven of 22 subjects who received lofexidine were blindly rated on the Clinical Global Scale-Improvement as either much improved or very much improved compared to none of 22 subjects who received placebo. The mean score on the parent-rated hyperactivity index improved by 29% in the lofexidine group and 18% in the placebo group, which was not a significant difference. On the Continuous Performance Test, commission errors decreased by 25% and omission errors by 20% in the lofexidine group, compared with increases of 33% in commission errors and of 36% in omission errors in the placebo group. Tic severity decreased by 27% in the lofexidine group, compared to 0% in the placebo group. One lofexidine subject with sedation withdrew at week 4. Lofexidine was associated with insignificant decreases in blood pressure and pulse. Lofexidine appears to be a safe and effective treatment for children with tic disorders and ADHD.

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Author information

Author/s: Niederhofer, Helmut (H); Staffen, Wolfgang (W); Mair, Alois (A);

Affiliation: Christian Doppler Klinik, Department of Neurology, Salzburg, Austria. helmut.niederhofer(-atsign-)uibk.ac.at

Journal and publication information

Publication Type: Clinical Trial; Journal Article; Randomized Controlled Trial; Retracted Publication

Journal: Journal of psychopharmacology (Oxford, England) (J Psychopharmacol), published in United States. (Language: eng)

Reference: 2003-Mar; vol 17 (issue 1) : pp 113-9

Dates: Created 2003/04/08; Completed 2003/07/22; Revised 2007/11/15;

PMID: 12680748, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

Comments and Corrections

CommentIn: J Psychopharmacol. 2004 Sep;18(3):291-2. (PMID: 15358974)

RetractionIn: J Psychopharmacol. 2004 Jun;18(2):146. (PMID: 15260900)

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adolescent
Adrenergic Agonists - adverse effects; therapeutic use
Analysis of Variance
Attention Deficit Disorder with Hyperactivity - drug therapy
Blood Pressure - drug effects
Child
Clonidine - adverse effects; analogs & derivatives; therapeutic use
Double-Blind Method

Associated Chemicals: Adrenergic Agonists (0) ; lofexidine (31036-80-3) ; Clonidine (4205-90-7)

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