Objective: The efficacy and side effects of buspirone in treatment of children with attention-deficit/hyperactivity disorder (ADHD) compared with methylphenidate (MPH). Method: A total of 40 children aged 6-16 with ADHD as defined by DSM-IV-TR were randomized to buspirone (0.5 mg/kg/day) or methylphenidate (0.3-1 mg/kg/day) for a 8-week in a crossover study. The principle measures of outcome were the teacher and parent ADHD Rating Scale. Side effects were assessed by special side effect checklist of each drug.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104116168N1
Registration date:2011-06-12, 1390/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-12, 1390/03/22
Registrant information
Name
Mahin Eslami Shahrbabki
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 6328
Email address
m_eslami@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Neuroscience Research Center Kerman University of Medical Sciences
Expected recruitment start date
2010-09-11, 1389/06/20
Expected recruitment end date
2011-03-11, 1389/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Buspirone versus Methylphenidate in 6-16 aged children with Attention Deficit/Hyperactive Disorder(ADHD). A crossover study
Public title
Buspirone in ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ADHD diagnosis according to DSM-IV-TR criteria that scored above 20 in ADHD-Rating Scale. Exclusion criteria: evidence of a mental retardation(IQ<70) or a major psychiatric problem other than oppositional defiant disorder and conduct disorder or receiving any psychotropic medication through 2 weeks before initiating treatment; medical disorders that would preclude the safe use of methylphenidate or buspirone.
Age
From 6 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Neuroscience Research Center of Kerman University of Medical Sciences,Kerman-Iran
Street address
0pposit of Besat Clinic, Ebn-e-sina Street , Jahad Blv,Kerman, Iran
City
Kerman
Postal code
7619813159
Approval date
2011-03-16, 1389/12/25
Ethics committee reference number
48-89
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
hyperactivity, impulsivity and inattention symptoms according to parent and teacher point of view
Timepoint
every 2 weeks
Method of measurement
ADHD Rating Scale(parent and teacher form)
Secondary outcomes
1
Description
side effects include increase or decrease of appetite,weight and sleep,tic,stomachach
Timepoint
every 2 weeks
Method of measurement
Checklist of each drug side effects
Intervention groups
1
Description
Intervention 1: buspirone was initiated with 0/5 mg/kg/day to maximum 45mg/day.
Category
Treatment - Drugs
2
Description
Intervention 2: Methylphenidate was initiated with 0/5-1 mg/kg/day and adjusted to maximum 60 mg per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital ,Jomhori Blvd, Kerman,IRAN and Besaat Clinic , Ebn-e- Sina Street Jahad Blv