Aripiprazole shows comparable efficacy to Haloperidol and better tolerability in paediatric Tic disorders

ISRCTN	ISRCTN63930220
DOI	https://doi.org/10.1186/ISRCTN63930220
Protocol serial number	N/A
Sponsor	Asan Medical Centre (South Korea)
Funder	Investigator initiated and funded (South Korea)

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 of protocol

Not provided at time of registration

Contact information

Prof Hanik Yoo
Scientific

Department of Psychiatry
University of Ulsan College of Medicine
Asan Medical Centre
388-1 Pungnap-2dong, Songpa-gu
Seoul
138-736
Korea, South

Email	hiyoo@amc.seoul.kr

Study information

Primary study design	Interventional
Study design	Single-centre, open, parallel trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ArHdTic
Study objectives	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).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Aripiprazole, haloperidol
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).
Key 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).
Completion date	30/03/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	01/08/2005
Date of final enrolment	30/03/2007

Locations

Countries of recruitment

Korea, South

Study participating centre

Department of Psychiatry

Seoul
138-736
Korea, South

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan