title: 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.
  
  
  METHODS
  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 or =4 by the end of week 3 were withdrawn from the trial.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.affiliation: Department of Child and Adolescent Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University, Shanghai, China.
authors.forename: Ya-song
authors.initials: YS
authors.lastname: Du
authors.forename: Hua-fang
authors.initials: HF
authors.lastname: Li
authors.forename: Alasdair
authors.initials: A
authors.lastname: Vance
authors.forename: You-quan
authors.initials: YQ
authors.lastname: Zhong
authors.forename: Fu-yong
authors.initials: FY
authors.lastname: Jiao
authors.forename: Hui-mei
authors.initials: HM
authors.lastname: Wang
authors.forename: Min-jie
authors.initials: MJ
authors.lastname: Wang
authors.forename: Lin-yan
authors.initials: LY
authors.lastname: Su
authors.forename: De-li
authors.initials: DL
authors.lastname: Yu
authors.forename: Shi-wei
authors.initials: SW
authors.lastname: Ma
authors.forename: Jie-bao
authors.initials: JB
authors.lastname: Wu
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000316:Adrenergic alpha-Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002681:China; D003000:Clonidine / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D009460:Neurologic Examination / Q000187:drug effects; D013981:Tic Disorders / Q000188:drug therapy*; D005879:Tourette Syndrome / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000316:Adrenergic alpha-Agonists; D003000:Clonidine