Evaluation of the efficacy of the methylphenidate in combination with magnesium and methylphenidate with placebo in patients with attention deficit hyperactivity disorder
The participants in the study are selected from among the referrals to Ziaeian Hospital based on inclusion criteria. Diagnosis of ADHD is performed by a child and adolescent psychiatrist.The total number of samples is 62 patients. Patients will be divided randomly in two group of 31 patients. The first group will receive methylphenidate and magnesium, the second group will receive methylphenidate and placebo, for 8 weeks. Patients are evaluated before intervention, 4 and 8 weeks after intervention. The severity of the symptoms is evaluated by the Conner's Rating Scale questionnaire of parents and ADHD Rating Scale. Side effects will be recorded in 4 and 8 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1-Age between 8-16 years old
2-Diagnosis of ADHD by the pediatric psychiatrist
3-Lack of mental retardation
4-No history of epilepsy and seizure
5-Intake methylphenidate tablet as the main method of drug therapy
6-consent of the patient and parents to participate in the research.
Exclusion criteria: 1-Renal failure
2-intolerance to magnesium
Intervention groups
The first group received methylphenidate and magnesium at a dose of 125 mg/day for patients less than 35 kg and 250 mg/day for patients more than 35 kg.The second group received methylphenidate and placebo.
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of the methylphenidate in combination with magnesium and methylphenidate with placebo in patients with attention deficit hyperactivity disorder
Public title
The effect of magnesium in patients with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 8-16 years old
Diagnosis of ADHD by the pediatric psychiatrist
Lack of mental retardation
No history of epilepsy and seizure
Intake methylphenidate tablet as the main method of drug therapy
Consent of the patient and parents to participate in the research
Exclusion criteria:
Renal failure
intolerance to magnesium
Age
From 8 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and physician will be blind about drug
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Pharmaceutical Sciences
Street address
#99, The First of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
19395-6466
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
IR.IAU.PS.REC.1396.236
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Scores in Conner's Parent Rating Scale questionnaire
Timepoint
Before, 4 weeks and 8 weeks after intervention
Method of measurement
Conner's Parent Rating Scale questionnaire
2
Description
Scores in ADHD Rating Scale questionnaire
Timepoint
Before, 4 weeks and 8 weeks after intervention
Method of measurement
ADHD Rating Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients will receive 0.3 to 2 mg/kg/day methylphenidate tablet and magnesium at a dose of 125 mg/day for patients less than 35 kg and 250 mg/day for patients more than 35 kg for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: patients will receive 0.3 to 2 mg/kg/day methylphenidate tablet and placebo for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ziaeian hospital
Full name of responsible person
Fatemeh Ajorloo
Street address
Abouzar St, District 17, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6810
Email
fateme.ajorloo@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Yakhchal St, Shariati St.
City
Tehran
Province
Tehran
Postal code
19395-6466
Phone
+98 21 2264 0051
Email
fhashemian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
#99, the first of Yakhchal Ave., Gholhak, Shariati St.
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
r_abrishami@iaups.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Effatpanah
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Enghelab avenue, Tehran University of Medical Sciences.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 2264 0051
Email
m.effatpanah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
#99, Yakhchal Ave., Shariati st.
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0051
Email
r_abrishami@iaups.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available