Randomized double-blind multicentre placebo-controlled clinical trial of the clonidine adhesive patch for the treatment of tic disorders.
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 or =4 by the end of week 3 were withdrawn from the trial.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.
Du
Ya-song
YS
Department of Child and Adolescent Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University, Shanghai, China.
Li
Hua-fang
HF
Vance
Alasdair
A
Zhong
You-quan
YQ
Jiao
Fu-yong
FY
Wang
Hui-mei
HM
Wang
Min-jie
MJ
Su
Lin-yan
LY
Yu
De-li
DL
Ma
Shi-wei
SW
Wu
Jie-bao
JB
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
D000316:Adrenergic alpha-Agonists; D003000:Clonidine