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

Aust N Z J Psychiatry. 2008 Sep;42(9):807-13. doi: 10.1080/00048670802277222.


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 or =4 by the end of week 3 were withdrawn from the trial.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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adrenergic alpha-Agonists / administration & dosage*
  • Adrenergic alpha-Agonists / adverse effects
  • Child
  • China
  • Clonidine / administration & dosage*
  • Clonidine / 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


  • Adrenergic alpha-Agonists
  • Clonidine