Randomized double-blind multicentre placebo-controlled clinical trial of the clonidine adhesive patch for the treatment of tic disorders.

Abstract

OBJECTIVE:

The aim of the present study was to evaluate the therapeutic effectiveness and safety of the clonidine adhesive patch in treating tic disorders.

METHOD:

A total of 437 patients, who met Chinese Classification of Mental Disorders-third edition diagnostic criteria for transient tic disorder (5%), chronic motor or vocal tic disorder (40%) or Tourette disorder (55%), aged 6-18 years, were divided randomly into an active treatment group and a clinical control group. Participants in the active treatment group were treated with a clonidine adhesive patch and participants in the clinical control group with a placebo adhesive patch for 4 weeks. The dosage of the clonidine adhesive patch was 1.0mg, 1.5mg or 2.0mg per week, depending on each participant's bodyweight. Participants whose Yale Global Tic Severity Scale (YGTSS) score decreased <30% and Clinical Global Impression score was > or =4 by the end of week 3 were withdrawn from the trial.

RESULTS:

After 4 weeks of treatment the active treatment group participants' YGTSS score was significantly lower than that of the clinical control group (F=4.63, p=0.03). Further, the active treatment group had a significantly better therapeutic response than the clinical control group (chi(2)=9.15, p=0.003). The response rate in the active treatment group was 68.85% compared to 46.85% in the clinical control group (chi(2)=16.98, p=0.0001). The rate of adverse events was low (active treatment group, 3.08%; clinical control group, 7.21%) and did not differ between the two groups.

CONCLUSIONS:

The clonidine adhesive patch is effective and safe for tic disorders.

• Authors: Ya-song Du, Hua-fang Li, Alasdair Vance, You-quan Zhong, Fu-yong Jiao, Hui-mei Wang, Min-jie Wang, Lin-yan Su, De-li Yu, Shi-wei Ma, Jie-bao Wu
• Journal: The Australian and New Zealand journal of psychiatry (Aust N Z J Psychiatry) Vol. 42 Issue 9 Pg. 807-13 (Sep 2008) ISSN: 1440-1614 [Electronic] England
• PMID: 18696285 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic alpha-Agonists
• Clonidine

Topics

• Administration, Cutaneous
• Adolescent
• Adrenergic alpha-Agonists (administration & dosage, adverse effects)
• Child
• China
• Clonidine (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug-Related Side Effects and Adverse Reactions
• Female
• Humans
• Male
• Neurologic Examination (drug effects)
• Tic Disorders (drug therapy)
• Tourette Syndrome (drug therapy)
• Treatment Outcome