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Melatonin Effects on Sleep Patterns, Symptoms of Hyperactivity and Attention Deficiency in Ritalin Treated Children with Attention Deficit Hyperactivity Disorder: A Randomized Double Blind Clinical Trial

Protocol summary

Summary
The objective of this study is evaluating melatonin effects on sleep patterns, symptoms of hyperactivity and attention deficiency in ritalin treated children with attention deficit hyperactivity disorder. forty four children referring to private psychology clinic at the age range of 7-12 who meet the inclusion criteria will divide in to two groups in a double blind permuted block randomized allocation design based on gender blocks. One group taking melatonin (3or6mg based on weight: 3mg in children under 30kg and 6mg in children above 30kg according to Kristiaan and colleagues (KRISTIAAN, HEIJDEN et al. 2007) combined with Ritalin (1mg/kg), and the other group taking placebo combined with Ritalin (1mg/kg). In the first visit, personal and demographic questionnaires, special tests for ADHD (based on diagnostic criteria for DSM-IV) such as ADHD Rating Scale, SDSC (Sleep Disturbance Scale for Children) sleep questionnaire will complete by mothers; and then, anthropometric measurements in standard situation will perform. ADHD rating scale and SDSC sleep questionnaires will complete by mothers at baseline, and will repeat at 2, 4, and 8 weeks after the treatment. Anthropometric assessments will done at baseline and will repeat 8 weeks after the treatment. At the end of study, the stimulant drug side effects questionnaire will complete by mothers; then, the side effects will compare between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203167462N4
Registration date: 2012-03-17, 1390/12/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Mohammad Reza Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 3540
Email address
pprc@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-17, 1390/12/27
Expected recruitment end date
2012-06-05, 1391/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Melatonin Effects on Sleep Patterns, Symptoms of Hyperactivity and Attention Deficiency in Ritalin Treated Children with Attention Deficit Hyperactivity Disorder: A Randomized Double Blind Clinical Trial
Public title
Melatonin Effects in Ritalin Treated Children with Attention Deficit Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age range of 7-12; ADHD combined form; Clinical need to treat with Methylphenidate; parental consent and child ascent Exclusion criteria: any confounding co-morbiditis; any drug supplements or narcotics consumption; Children with history of major prenatal complications such as prematurity, low birth weight (reported by parents), any past or present psychosis, comorbid tourette syndrome, celiac, phenylketonuria, autism, or other persistent developmental disorders
Age
From 7 years old to 12 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
Tehran University of Medical Sciences
Street address
Research Deputy of Tehran University of Medical Sciences, Keshavarz Avenue, Tehran. Iran
City
Tehran
Postal code
Approval date
2011-04-16, 1390/01/27
Ethics committee reference number
31807

Health conditions studied

1

Description of health condition studied
Attention Deficit Hyperactivity Disorder (ADHD)
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention

Primary outcomes

1

Description
Sleep disorders score
Timepoint
0-2-4-8 weeks
Method of measurement
Sleep disorders scale for chilldren (SDSC)

2

Description
Appetite score
Timepoint
0-2-4-8 weeks
Method of measurement
Standard appetite questionnaire for chilldren

3

Description
Attention deficiency score and Hyperactivity score
Timepoint
0-2-4-8 weeks
Method of measurement
ADHD rating scale for children (complited by parents)

Secondary outcomes

1

Description
Stimulants side effects
Timepoint
week 8
Method of measurement
Stimulants side effects questionnare

Intervention groups

1

Description
Control: Methylphenidate (Ritalin: 1mg/kg) combined with Placebo taking 1 hour befor bed time
Category
Treatment - Drugs

2

Description
Intervention group: Methy phenidate (Ritlin: 1mg/kg) combined with Melatonin (Nutricentury: 3 or 6 mg ) taking 1 hour befor bed time
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Private clinic
Full name of responsible person
Dr. Mohammad Reza Mohammadi
Street address
Dr. Mohammad Reza Mohammadi private clinic, Zafar street, Vali-Asr street, Tehran. Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Ahadi
Street address
Rasearch Deputy of Tehran University of Medical Sciences, Keshavarz Avenue, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 University of Medical Sciences
Full name of responsible person
Seyed Ali Mostafavi
Position
B.S.
Other areas of specialty/work
Street address
4th floor, Nutrition department, Health faculty, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
00
Fax
Email
mostafavi.n80@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Mostafavi
Position
BS
Other areas of specialty/work
Street address
4th floor, Nutrition department, Health faculty, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
00
Fax
Email
mostafavi.n80@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Ali Mostafavi
Position
BS
Other areas of specialty/work
Street address
4th floor, Nutrition department, Health faculty, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
00
Fax
Email
mostafavi.n80@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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