Aripiprazole shows comparable efficacy to Haloperidol and better tolerability in paediatric Tic disorders
| ISRCTN | ISRCTN63930220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63930220 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/05/2008
- Registration date
- 04/06/2008
- Last edited
- 17/06/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Hanik Yoo
Scientific
Scientific
Department of Psychiatry
University of Ulsan College of Medicine
Asan Medical Centre
388-1 Pungnap-2dong, Songpa-gu
Seoul
138-736
Korea, South
| hiyoo@amc.seoul.kr |
Study information
| Study design | Single-centre, open, parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ArHdTic |
| 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(s) | Ethics approval received from the Institutional Review Board of Asan Medical Centre, Seoul, South Korea on the 30th July 2005 (ref: 2005-0163). |
| Condition | Tic disorders |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Aripiprazole, haloperidol |
| Primary outcome measure | 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 measures | 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). |
| Overall study start date | 01/08/2005 |
| Overall study end date | 30/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/08/2005 |
| Recruitment end date | 30/03/2007 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Department of Psychiatry
Seoul
138-736
Korea, South
138-736
Korea, South
Sponsor information
Asan Medical Centre (South Korea)
Hospital/treatment centre
Hospital/treatment centre
Department of Psychiatry
University of Ulsan College of Medicine
388-1 Pungnap-2dong
Songpa-gu
Seoul
138-736
Korea, South
| hiyoo@amc.seoul.kr | |
| Website | http://www.amc.seoul.kr/eng/index.jsp |
"ROR" |
https://ror.org/03s5q0090 |
Funders
Funder type
Other
Investigator initiated and funded (South Korea)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
