Comparison the effect of Piracetam versus placebo on control of attention deficit-hyper activity disorder symptoms in Iranian children and adolescents, a double blind randomized clinical trial
In this research, we intended to study the effect of Piracetam- a cognitive enhancer & brain blood flow enhancer with glutamergic effects - on symptom control of ADHD.This study is a double blind placebo controlled clinical trial.
With block randomization method; 36 participants randomly divided in to case & control groups.Both groups will receive Methylphenidate as a standard treatment.Then drug or placebo will prescribed up to 70 mg/kg/day additionally.
At the beginning of study, 3 & 6 weeks latter 3 questionnaire include Parent's conners questionaire, CGAS & Rachel & Klein Side effects Form will completed individually.
Finally, the gathered data will analyzed statistically.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303036923N2
Registration date:2013-08-01, 1392/05/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-01, 1392/05/10
Registrant information
Name
Elham Shirazi
Name of organization / entity
Iran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 5680
Email address
eshirazi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research Tehran University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Piracetam versus placebo on control of attention deficit-hyper activity disorder symptoms in Iranian children and adolescents, a double blind randomized clinical trial
Public title
Comparison the effect of Piracetam versus placebo on control of Attention deficit-hyper activity disorder symptoms.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age 6-16; Diagnosis of ADHD for the first time
Exclusion criteria : IQ<70 ; Having other chronic medical illnesses; Be under other medications; Any serious or sever complication during study; Refusal of child or parent to continue the study
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:
36
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
Vice chancellor for Research Tehran University of Medical Sciences
Street address
Vice chancellor for Research Tehran University of Medical Sciences, 7th Floor, Central Building of Tehran University of Medical Sciences, Corner of Qods St, Keshavarz Blvd,Tehran, Iran
City
Tehran
Postal code
Approval date
2013-07-01, 1392/04/10
Ethics committee reference number
19912
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, Impulsivity & Behavioral indecies
Timepoint
At the begining,3 weeks later & 6 weeks later
Method of measurement
Conner's parents questionaire
2
Description
Child's general function
Timepoint
At the begining of study , 3 weeks later , 6 weeks later
Method of measurement
CGAS questionare
Secondary outcomes
1
Description
Drug complication
Timepoint
3 weeks after begining of the study & 6 weeks later
Method of measurement
Rachell & klein Side effects Form
Intervention groups
1
Description
Intervention group will receive 70 mg/kg/day of Piracetam syrup (product of Daroo pakhsh company which contains 33.3 g/dl of drug) every morning , half an hour after taking Methylphenidate tablet.
Category
Treatment - Drugs
2
Description
Control group will receive 70 mg/kg/day of placebo ( Sucrose solution in the same package and same dilution as Piracetam syrup) half an hour after taking their Methylphenidate tablet.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Institute of Psychitry
Full name of responsible person
Dr Maryam Akbari, Psychiatry Resident
Street address
Tehran Institute of Psychiatry, Shahid Mansouri St, Niayesh St, Sattarkhan St, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Ali Asghar Children Hospital
Full name of responsible person
Dr Elham Shirazi, Associate Professor, Board of Subspeciality of Child and Adolescent Psychiatry
Street address
Ali Asghar Children Hospital, Zafar St, Modarres Ave, Tehran , Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research Tehran University of Medical Sciences
Full name of responsible person
Dr Jalili
Street address
Vice chancellor for Research Tehran University of Medical Sciences, 7th Floor, Central Building of Tehran University of Medical Sciences, Corner of Qods St, Keshavarz Blvd,Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research Tehran 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
Tehran Institute of Psychiatry
Full name of responsible person
Dr Maryam Akbari
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Tehran Institute of Psychiatry, Shahid Mansouri St, Niayesh St, Sattarkhan St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6655 1515
Fax
Email
maryam1135@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Institute of Psychitry
Full name of responsible person
Dr Elham Shirazi
Position
Associate Professor, Board of Subspeciality of Child and Adolescent Psychiatry
Other areas of specialty/work
Street address
Tehran Institute of Psychiatry, Shahid Mansouri St, Niayesh St, Sattarkhan St, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6655 1515
Fax
Email
eshirazi@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Institute of Psychiatry
Full name of responsible person
Dr Maryam Akbari
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Tehran Institue of Psychiatry, Shahid Mansouri St, Niayesh St, Sattarkhan St, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6655 1515
Fax
Email
maryam1135@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)