Efficacy of pramipexole treatment and methylphenidate in children with attention deficit hyperactivity disorder, compared with placebo and methylphenidate.
Aim of this study is Evaluating the effects of combining drugs pramipexole and methylphenidate in the treatment of Attention Deficit Hyperactivity Disorder children.Children should be 6-12 years old and diagnostic criteria according to DSM IV-IR and have Conners test. In case of any medical conditions or mental disability or a history of seizures other than seizures associated with fever, are excluded. The sample is 10 children of ADHD that referred to Golestan Hospital. Conners Scale to help identify systematically used in ADHD and in both teacher and parent designed. Patients treated with methylphenidate and pramipexole during 6 weeks. The starting dose of methylphenidate considered to be 0.3mg / kg in two divided doses and increase based on the need to 1mg / kg.Pramipexole starts with Pramipexole at nights. Then gradually increase the dose based on clinical response and tolerability of side effects.And the final dose of up to 0.5mg pramipexole a day.As well as placebo in terms of shape, color, smell and taste will be like pramipexole
General information
Acronym
Attention Deficit Hyperactivity Disorder
IRCT registration information
IRCT registration number:IRCT201612253979N6
Registration date:2017-01-24, 1395/11/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-24, 1395/11/05
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
Vice chancellor for research Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
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 in children with attention deficit hyperactivity disorder, compared with placebo and methylphenidate.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children 6-12 years old;Having diagnostic criteria and testing Connors.
Exclusion criteria: medical conditions such as kidney failure and epilepsy;psychiatric disorders with a focus on DSM IV-TR; mental disability;history of seizures other than seizures associated with fever,need for dopaminergic drugs, levodopa, ranitidine, cimetidine
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
City
Ahvaz
Postal code
Approval date
2016-07-23, 1395/05/02
Ethics committee reference number
IR.AJUMS.REC.1395.355
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 weeks of the study
Method of measurement
The Conner's parent rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: children treat with methylphenidate and pramipexole during 6 weeks. The starting dose of methylphenidate considered to be 0.3mg / kg in two divided doses and increase to 1mg/kg based on need. Pramipexole starts with dose of 0.125mg in nights Then gradually increase the dose based on clinical response and tolerability of side effects. The final dose of up to 0.5mg pramipexole a day.
Category
Treatment - Drugs
2
Description
Treatment groups: children 6 weeks will be treated with methylphenidate and placebo. Placebo pill shape, color, smell and taste will be like pramipexole.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Child and Adolecent Psychiatry Clinic, Golestan Hospital
Full name of responsible person
Forugh Riahi
Street address
Psychiatry Group, Golestan Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Devision, Ahvaz Jondishapoor Medical University
Full name of responsible person
Behzad Sharif Makhmal Zade
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Devision, Ahvaz Jondishapoor Medical University
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Forough Riahi
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
riahi13@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Forough Riahi
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
riahi13@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Samar Sadat Marashi
Position
Other areas of specialty/work
Street address
Ahvaz Golestan Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3374 3038
Fax
Email
samar.marashi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)