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30 August 2008
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| [ Print-friendly version ] |
| Aripiprazole shows comparable efficacy to Haloperidol and better tolerability in paediatric Tic disorders |
| ISRCTN | ISRCTN63930220 |
| ClinicalTrials.gov identifier | |
| Public title | Aripiprazole shows comparable efficacy to Haloperidol and better tolerability in paediatric Tic disorders |
| Scientific title | |
| Acronym | ArHdTic |
| Serial number at source | N/A |
| Study hypothesis |
Tics are defined as rapid and repetitive muscle contractions resulting in movements or vocalisations that are experienced as involuntary. Tic disorders are a group of neuropsychiatic disorders that generally begin in childhood or adolescence and may be constant or wax and wane over time.
Aripiprazole is a candidate atypical antipsychotic for patients with tic disorders due to its unique pharmacodynamic property of dopamine partial agonistic activity with fewer and milder side effects. This study was conducted to determine whether aripiprazole has comparable efficacy to haloperidol, the most widely used typical antipsychotic in the treatment of tic disorders, but which has a higher tolerability. The pilot study and efficacy study of this trial have been published as follows: 1. A pilot study of aripiprazole in children and adolescents with Tourette's disorder (http://www.ncbi.nlm.nih.gov/pubmed/16958578) 2. An open-label study of the efficacy and tolerability of aripiprazole for children and adolescents with tic disorders (http://www.ncbi.nlm.nih.gov/pubmed/17685747) |
| Ethics approval | Ethics approval received from the Institutional Review Board of Asan Medical Centre, Seoul, South Korea on the 30th July 2005 (ref: 2005-0163). |
| Study design | Single-centre, open, parallel trial |
| Countries of recruitment | South Korea |
| Disease/condition/study domain | Tic disorders |
| Participants - inclusion criteria |
1. Aged 6 - 18 years
2. Gender: male or female 3. Diagnosis: tic disorders according to the Korean version of the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (KSADS-PL) 4. Severity: total tic scores greater than or equal to 22 on the Korean version of the Yale Global Tic Severity Scale |
| Participants - exclusion criteria |
1. Current mood disorders
2. Psychotic symptoms 3. Anxiety disorders except obsessive-compulsive disorder, which is the most common comorbid anxiety disorder in tic patients 4. Subjects with an intelligence quotient (IQ) of 70 or less by using the Korean version of the Wechsler Intelligence Scale for Children-Revised 5. Previous or current seizure episodes, electroencephalogram (EEG) abnormalities 6. Subjects had used aripiprazole previously 7. Any significant medical problems 8. Pregnancy |
| Anticipated start date | 01/08/2005 |
| Anticipated end date | 30/03/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 50 |
| Interventions |
In the aripiprazole group, a child psychiatrist initially prescribed 5.0 mg/d of aripiprazole, and then increased the dose in 5.0 mg/d increments as tolerated at visits every two weeks. The dose was reduced by 2.5 mg/d to 5.0 mg/d when intolerable side effects emerged. The maximum allowable dose was 20 mg/d.
In the haloperidol group, haloperidol was titrated from a commencing dose of 0.75 mg/d to a maximum tolerated dose of 4.5 mg/d in 1.5 - 3.0 mg increments at visits every other week The total duration of treatment and follow-up were eight weeks. |
| Primary outcome measure(s) |
Yale Global Tic Severity Scale (YGTSS): the YGTSS is a semi-structured clinical interview designed to assess current tic severity, which yields three summary scores.
Both primary and secondary outcomes were measured at every visit (baseline, two weeks, four weeks, six weeks, eight weeks). |
| Secondary outcome measure(s) |
1. The Clinical Global Impressions-Improvement Scale (CGI-I)
2. The CGI-Severity of Illness Scale (CGI-S) 3. The Extrapyramidal Symptom Rating Scale (ESRS) Both primary and secondary outcomes were measured at every visit (baseline, two weeks, four weeks, six weeks, eight weeks). |
| Sources of funding | Investigator initiated and funded (South Korea) |
| Trial website | |
| Publications | |
| Contact name | Prof Hanik Yoo |
| Address |
Department of Psychiatry
University of Ulsan College of Medicine Asan Medical Centre 388-1 Pungnap-2dong, Songpa-gu, |
| City/town | Seoul |
| Zip/Postcode | 138-736 |
| Country | Korea, South |
| hiyoo@amc.seoul.kr | |
| Sponsor | Asan Medical Centre (South Korea) |
| Address |
Department of Psychiatry
University of Ulsan College of Medicine 388-1 Pungnap-2dong Songpa-gu |
| City/town | Seoul |
| Zip/Postcode | 138-736 |
| Country | Korea, South |
| hiyoo@amc.seoul.kr | |
| Sponsor website: | http://www.amc.seoul.kr/eng/index.jsp |
| Date applied | 16/05/2008 |
| Last edited | 17/06/2008 |
| Date ISRCTN assigned | 04/06/2008 |
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