Risperidone versus behaviour therapy in the treatment of tic disorders - a randomized single-blinded trial

Completed

Conditions: neuropsychiatrische aandoening (syndroom van Gilles de la Tourette en aanverwante chronische ticstoornissen)
chronic tic disorder
Gilles de la Tourette syndrome

Registration Number: NL-OMON38252

Lead Sponsor: HagaZiekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Patients have to meet DSM-IV criteria for GTS or CTD, and will be included according to the Diagnostic Confidence Index. Both children and adults are included, ranging from 6 to 65 years of age. Written informed consent is necessary to participate in the study by the patient. In case the patient is under age of 16 a written consent of parents is necessary before a patient is included in the study.

Exclusion Criteria

Exclusion criteria are: severe major depression, psychosis, addiction, mental deficiency, known cardiovascular disease, family history of QT prolongation, bradycardia, other medication known to prolong QT interval, and inability to read/ speak Dutch. Exclusion criteria will be established
using the Mini International Neuropsychiatric Interview for adults, or the KIDDIE-SADS for children.Patients need to be free of antipsychotic medication for at least four weeks prior to entering the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure will be tic severity according to the Yale Global Tic<br /><br>Severity Scale (YGTSS, Leckman et al, 1989) directly post treatment ( after 12<br /><br>weeks), as measured by trained experts, blinded for the allocated treatment.<br /><br>The YGTSS is a widely used clinical rating scale that provides information on<br /><br>tic severity for motor and vocal tics in five dimensions: number, frequency,<br /><br>intensity, complexity, and interference. A rating of impairment is added to<br /><br>provide a total Tic severity score that ranges from 0 (no tics) to 55 (severe<br /><br>tics).<br /><br>The YGTSS has demonstrated satisfactory convergent and discriminant validity<br /><br>and interrater reliability.</p><br>

Secondary Outcome Measures