Efficacy of pramipexole treatment and methylphenidate in children with attention deficit hyperactivity disorder, compared with placebo and methylphenidate
Investigating the effect of primepxol and methylphenidate combination on patients suffering from Attention Deficit Hyperactivity Disorder (ADHD)
Design
A parallel, double-blind, randomized clinical trial with control group; community based and pragmatic. There will be two groups of drugs including primaxyxol and placebo.
Settings and conduct
This study will be done in Ahvaz Golestan Hospital. Researchers and patients will not know about their received medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 6 to 12 years whose condition is confirmed by the Conner test
Exclusion criteria: There is a psychiatric disorder and other medical conditions
Intervention groups
Intervention group: The starting dose of methylphenidate will be 0.3mg / kg in two divided doses and will be increased to 1mg / kg based on the need. Pramipexole starts at 0.125 mg per night and will be increased to 0.5 mg. The treatment response will be measured with the Conner's questionnaire before treatment and after 2, 4, 6, 8, 10, and 12 weeks.
Control group: The control group will receive capsules that are similar to primiplex in shape,color and smell
Main outcome variables
Attention deficit hyperactivity score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100520003979N7
Registration date:2018-06-11, 1397/03/21
Registration timing:registered_while_recruiting
Last update:2018-06-11, 1397/03/21
Update count:0
Registration date
2018-06-11, 1397/03/21
Registrant information
Name
Forugh Riahi
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
riahi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of pramipexole treatment and methylphenidate in children with attention deficit hyperactivity disorder, compared with placebo and methylphenidate
Public title
Efficacy of pramipexole treatment and methylphenidate for attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of children aged 6 to 12 years
Having diagnostic criteria based on IV-IRDSM and Conners test
Exclusion criteria:
The presence of other medical conditions (heart problem, kidney failure, epilepsy, etc.)
The presence of other serious psychiatric disorders such as mood disorders, penetrating disorders, and
The presence of symptoms of mental disability
a history of seizure
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
10
Actual sample size reached:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the therapist are not informed about the medicine they received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz JundiShapour University of Medical Sciences Ethics Committee
Street address
Golestan Blvd, Ahvaz, Khoozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
IR.AJUMS.REC.1396.496
Health conditions studied
1
Description of health condition studied
attention deficit hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Attention Deficit Hyperactivity Disorder.
Timepoint
Befor intervention- the end of second, fourth and sixth,eighth, tenth,twelfth weeks of the study
Method of measurement
The Conner's parent rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: children will be treated with Methylphenidate and Pramipexole during 12 weeks. The starting dose of methylphenidate will be considered to be 0.3mg / kg in two divided doses and will be increased to 1mg/kg based on need. Pramipexole starts with 0.125 mg every night. Then the dose will gradually be increased based on clinical response and tolerance to side effects. The final dose for pramipexole will be up to 0.5mg a day.
Category
Treatment - Drugs
2
Description
Control group: children will be treated with methylphenidate and placebo during 12 weeks. Placebo pill are will be similar to shape, color, smell and taste are like pramipexole.