Evaluation of methylphenidate’s effect on motor skills disorder in children with ADHD and developmental coordination disorder referred to Shafa hospital, Rasht 1390
This research has two parts. In the first part, a child and adolescent psychiatrist does clinical interview and K-SAD's semi structure interview (timetable Cady for emotional disorders and schizophrenia school aged children). The patients with combined ADHD and DCD are enrolled. After filling demographic questionnaire and taking drug history, we perform physical examination and complete ADHD symptoms checklist. Then we try to estimate effective methylphenidate (MPH) dosage. This part lasts 4 weeks. Through a block randomization, each child receives 0.5, 0.75, or 1 mg/kg of MPh, or placebo each week and his/ her mother fills ADHD symptoms checklist. After one week washout period, we perform second part of the research. The patients are assigned into groups A or B. Each group receives MPH/ placebo or placebo/ MPH for one week. We perform BOT-2 test before intervention and at the end of the first and second weeks (3 times). The total duration of this research (including two parts) is 7 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107071483N2
Registration date:2011-07-13, 1390/04/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-07-13, 1390/04/22
Registrant information
Name
Mir Mohammad Jalali
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1324 3085
Email address
mmjalali@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research- Guilan University of Medical Sciences- Iran
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of methylphenidate’s effect on motor skills disorder in children with ADHD and developmental coordination disorder referred to Shafa hospital, Rasht 1390
Public title
Methylphenidate effect on fine motor skills of children with attention deficit/hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 6-11 years old, IQ score more than 70 on Raven's intelligence test, No associated psychiatric disorders (pervasive developmental disorders, anxiety, conduct, mood disorders and schizophrenia), recent disease of ADHD-C or drug therapy less than 3 months prior to the study, No medical diseases (neurologic problems, seizures, cerebral palsy, sensory deficits including vision and hearing)
Exclusion criteria: occurrence of side effects, poor compliance / irregular drug consumption
Age
From 6 years old to 11 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Namjoo Street, Rasht
City
Rasht
Postal code
41446-65385
Approval date
2011-07-05, 1390/04/14
Ethics committee reference number
190015212
Health conditions studied
1
Description of health condition studied
developmental coordination disorder
ICD-10 code
F82
ICD-10 code description
Specific developmental disorder of motor function
Primary outcomes
1
Description
BOT 2 score
Timepoint
before intervention, the end of first and second week
Method of measurement
BOT 2 test
Secondary outcomes
1
Description
measurement of effective dosage of methylphenidate
Timepoint
before intervention and the end of 1, 2, 3 and 4 week
Method of measurement
ADHD symptoms checklist
Intervention groups
1
Description
methylphenidate therapy for one week
Category
Treatment - Drugs
2
Description
placebo for one week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Dr Robabeh Soleimani Talemi
Street address
Shafa hospital, Heshmat Square, Rasht
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Abdorrasool Sobhani
Street address
Namjoo street- Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Robabeh Soleimani Talemi
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Shafa hospital, Heshmat square, rasht
City
Rasht
Postal code
41939-55599
Phone
+98 13 1666 6268
Fax
+98 13 1666 6268
Email
mmjalali@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Robabeh Soleimani Talemi
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Shafa hospital, Heshmat square, rasht
City
Rasht
Postal code
41939-55599
Phone
+98 13 1666 6268
Fax
+98 13 1666 6268
Email
mmjalali@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Robabeh Soleimani Talemi
Position
Assistant professor
Other areas of specialty/work
Street address
Shafa hospital, Heshmat square, Rasht
City
Rasht
Postal code
41939-55599
Phone
+98 13 1666 6268
Fax
+98 13 1666 6268
Email
mmjalali@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)