Effect of Ritalin with and without Melatonin on the quality of sleep and the severity of clinical symptoms in children with attention deficit hyperactivity disorder: a randomized clinical trial
To assess the effect of Ritalin with and without Melatonin on the quality of sleep and the severity of clinical symptoms in children with attention deficit hyperactivity disorder
Design
This is a randomized clinical trial, phase II, in which 48 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible children with attention deficit hyperactivity disorder who will refer to Besat Hospital during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 5 to 10 years;
Attention deficit hyperactivity disorder;
Sleep disorder
Exclusion criteria:
Phenylketonuria;
Depression;
Mental retardation;
Using hypnotic drugs
Intervention groups
Intervention group: Tablet Ritalin 5 mg to 40 mg daily for one month plus tablet Melatonin 3 mg once a night for 10 days
Control group: Tablet Ritalin 5 mg to 40 mg daily for one month
Main outcome variables
Primary outcome:
Assessing the sleep quality
Assessing the severity of clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N235
Registration date:2018-09-22, 1397/06/31
Registration timing:retrospective
Last update:2018-09-22, 1397/06/31
Update count:0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-07-11, 1397/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ritalin with and without Melatonin on the quality of sleep and the severity of clinical symptoms in children with attention deficit hyperactivity disorder: a randomized clinical trial
Public title
Effect of Ritalin with and without Melatonin on the quality of sleep and the severity of clinical symptoms in children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 5 to 10 years;
Attention deficit hyperactivity disorder;
Sleep disorder
Exclusion criteria:
Phenylketonuria;
Depression;
Mental retardation;
Using hypnotic drugs
Age
From 5 years old to 10 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-11-27, 1396/09/06
Ethics committee reference number
IR.UMSHA.REC.1396.581
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90.9
ICD-10 code description
Attention-deficit hyperactivity disorder, unspecified type
Primary outcomes
1
Description
Assessing the sleep quality
Timepoint
At baseline and then one and two months after intervention
Method of measurement
Using children sleep habit questionnaire (CSHQ)
2
Description
Assessing the severity of clinical symptoms
Timepoint
At baseline and then one and two months after intervention
Method of measurement
Using Conner questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tablet Ritalin 5 mg to 40 mg daily for one month plus tablet Melatonin 3 mg once a night for 10 days
Category
Treatment - Drugs
2
Description
Control group: Tablet Ritalin 5 mg to 40 mg daily for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
to Besat Hospital
Full name of responsible person
Ghazal Sami
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
medicine372@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Ghazal Sami
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
medicine372@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Afshin Fayazi
Position
Podiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
afshin_fay@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
Undecided - It is not yet known if there will be 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
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available