Condition category
Mental and Behavioural Disorders
Date applied
16/05/2008
Date assigned
04/06/2008
Last edited
17/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hanik Yoo

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Aripiprazole, haloperidol

Primary outcome measures

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 trial start date

01/08/2005

Overall trial end date

30/03/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

50

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

Trial participating centre

Department of Psychiatry
Seoul
138-736
Korea, South

Sponsor information

Organisation

Asan Medical Centre (South Korea)

Sponsor details

Department of Psychiatry
University of Ulsan College of Medicine
388-1 Pungnap-2dong
Songpa-gu
Seoul
138-736
Korea
South
hiyoo@amc.seoul.kr

Sponsor type

Hospital/treatment centre

Website

http://www.amc.seoul.kr/eng/index.jsp

Funders

Funder type

Other

Funder name

Investigator initiated and funded (South Korea)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes