neuropsychiatrische aandoening (syndroom van Gilles de la Tourette en aanverwante chronische ticstoornissen) chronic tic disorder Gilles de la Tourette syndrome
Conditions
Interventions
Randomization starts after the in- and exclusion criteria are checked.
Stratification is applied for patients under and above 18 years of age.
There are two treatment conditions:
1) Exposure and Resp
2) Risperidone
Treatment starts 2 weeks after inclusion so a baseline of home tic registration
will be available. The ERP condition consists of 12 sessions of 1 hour. In the
first two training sessi
Sponsors
HagaZiekenhuis
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure will be tic severity according to the Yale Global Tic Severity Scale (YGTSS, Leckman et al, 1989) directly post treatment ( after 12 weeks), as measured by trained experts, blinded for the allocated treatment. The YGTSS is a widely used clinical rating scale that provides information on tic severity for motor and vocal tics in five dimensions: number, frequency, intensity, complexity, and interference. A rating of impairment is added to provide a total Tic severity score that ranges from 0 (no tics) to 55 (severe tics). The YGTSS has demonstrated satisfactory convergent and discriminant validity and interrater reliability. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcome measures include ticfrequency at home and at the institute after 12 weeks, and tic severity and frequency at home and at the institute after 6 and 12 months (follow-up). General assessment of functioning and quality of life, cost-effectiveness, severity of premonitory sensations, side effects and severity of comorbidity will be measured as well, as are effects during half way of treatment (after 6 weeks). Prognostic factors for response on the two treatments will be analysed with the use of multivariate analysis. Ticfrequency at home will be measured by daily registrations by a parent/ partner of the patient. They count the number of tics in a 15 minute interval during a fixed time/ activity. Tic frequency at the institute will be measured by counting tics of videotaped YGTSS measures. Standardized videotaped tic counts of at least 5-minute samples have previously been found to provide reliable and stable measures of tic frequency and are sufficiently correlated with YGTSS ratings (Chapell et al., 2004). Quality of life is measured by the Gilles de la Tourette Syndrome*Quality of Life Scale(GTS-QOL, Cavanna et al, 2008). The GTS-QOL is a 27-item, patient-reported scale which measures GTS-specific health related quality of life on 4 subscales. The GTS-QOL demonstrated high reliability and test-retest reliability, and supported validity. The economic evaluation will use a societal perspective: we will document mental and general health care utilization (direct medical costs), travel to and from health care providers (non-medical costs) and productivity loss generated by absence from paid work (indirect costs).TIC-P (Trimbos/iMTA questionnaire for costs associated with psychiatric illness, Hakkaart-van Roijen, 2002) will be administered. The TiC-P is a generally applied tool to estimate health care utilisation and production losses by self-report from recipients (patients with mental health problems) in the Dutch health care | — |
Countries
Netherlands
Outcome results
None listed