Objective: The purpose of this study is to evaluate the safety and efficacy of Risperidone in comparison with Haloperidol for the treatment of Attention Deficit Hyperactivity Disorder in preschool children. Design: randomized, double blind study was designed: A child psychiatrist examines 46 children who are referred to child psychiatry clinic of Golestan hospital of Ahwaz. They must fullfill criteria based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision for Attention Deficit Hyperactivity Disorder. Participants:they are 46 children from both gender and three to six years old age. The inclusion criteria are Children from three to age six with Attention deficit hyperactivity disorder. They excludes from study if they have any other psychiatric comorbidity like mood disorder; anxiety disorder; psychotic disorder; mental retardation; tic and pervasive developemental disorder. They do not have to take any psychotropic medication two weeks before starting the study. Intervention: consent informant will be obtained from parents, the children randomly divided into two groups. Group one takes Haloperidol and the second one takes Risperidone. The clinician and parents are both blind to treatment. The starting dose of Risperidone is 0.25mg daily and it will increase every other week depending on clinical response and the maximum dose of Risperidone is 2 mg at the end of sixth week. Starting dose of Haloperidol is 0.5mg in two divided doses and will increase based on clinical response and tolerability and the maximum dose would be 0.075mg/kg. follow-up measures are the ADHD rating scale(ADHD-RS), Children Global Assessment Scale(C-GAS), Conners Rating Scale Parent(CRSP) and side effect questionarie. They will assess for 6 weeks at the baseline, 2 weeks, 4 weeks, 6 weeks after intervention. Statistician calculates the results statistically at the end.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082623766N1
Registration date:2015-09-14, 1394/06/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-14, 1394/06/23
Registrant information
Name
Leila Abdi
Name of organization / entity
Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
abdi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
All financial fees of this study would be supported by vice Chancellor of Research Ahwaz Jondishapour Medical University of Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Risperidon versus Haloperidol in the treatment of preschool children with attention deficit hyperactivity disorder
Public title
Haloperidol and Risperidone efficacy for Attention Deficit Hyperactivity Disorder treatment
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: three to six years old children with attention deficit hyperactivity disorder; parent consent; ADHD rating scale greater than 20 and C-GAS lower than 50.
exclusion criteria:any other medical or psychiatric comorbidity like mood disorder; anxiety disorder; mental retardation; psychotic disorder; tic; pervasive developemental disorder and taking any pharmacological or non pharmacological treatment in two weeks prior to study.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz Jondishapour University of Medical Sciences
Street address
Ethics Committee of Jondishapour University of Medical Sciences, university center, Golestan Boulevard
City
Ahwaz
Postal code
Approval date
2014-12-06, 1393/09/15
Ethics committee reference number
ajums.REC.13930305
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
hyperkinetic disorder
Primary outcomes
1
Description
Attention deficit hyperactivity disorder score
Timepoint
baseline and 2 weeks, 4weeks, 6weeks after intervention
baseline and 2 weeks, 4weeks, 6 weeks after intervention
Method of measurement
Conners Rating Scale-Parent version questionarie
Secondary outcomes
1
Description
Drug side effects
Timepoint
2 weeks, 4weeks, 6weeks after intervention
Method of measurement
Side effect questionaire
Intervention groups
1
Description
The second group took haloperidol orally with a starting dose of 0.5mg in two divided doses and it was increased depending on clinical response and tolerability. The maximum dose for haloperidol was 0.075mg/kg at the end of sixth week.
Category
Treatment - Drugs
2
Description
The first group took Risperidone tablet orally at the starting dose of 0.25mg and it was increased depending on clinical response and the maximum dose was 2mg at the end of sixth week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
psychiatric clinic of child and adolescent of Golestan hospital