Evaluate the effectiveness of cyproheptadine on prevention of sleep disorders and appetite caused by the consumption of methylphenidate in children with ADHD and its effects on the efficiency of methyl Fndyt
The aim of this study was to evaluate the efficacy of cyproheptadine on prevention of sleep disorders and anorexia in children with ADHD. Study Design: This was a prospective, double-blind study randomized Clinical trial to compare the effect of cyproheptadine with methyl Fenidayt insomnia and loss of appetite to reduce the effects caused by the drug deals. The study population consists of children over two years old and suffering from hyperactivity and poor concentration. Inclusion criteria: 1) patient satisfaction, 2) older than 3 years 3) non-use of concomitant medications that have a significant impact on sleep or appetite. Exclusion criteria: 1) the risk of renal failure 2) the risk of cardiovascular diseases 3) the risk of thyroid disease 4) sensitivity to cyproheptadine 5) intolerance side effects. Sample Size: 60. Interventions of the study are methylphenidate plus cyproheptadine and methylphenidate plus placebo and their effects on insomnia and anorexia. Intervention time: 2 months. Study outcomes: prevention of anorexia and insomnia caused by methylphenidate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070623099N1
Registration date:2015-10-18, 1394/07/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-18, 1394/07/26
Registrant information
Name
Faeze Kadkhoda Mezerji
Name of organization / entity
Mashhad University of Medical Siences, School Of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 58 3225 7970
Email address
kadkhodaf891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Siences
Expected recruitment start date
2015-04-12, 1394/01/23
Expected recruitment end date
2016-02-23, 1394/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effectiveness of cyproheptadine on prevention of sleep disorders and appetite caused by the consumption of methylphenidate in children with ADHD and its effects on the efficiency of methyl Fndyt
Public title
Cyproheptadine effect on insomnia and loss of appetite caused by methylphenidate in ADHD children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient satisfaction; age older than 3 years old; no use of concomitant medications that have a significant impact on sleep or appetite. Exclusion criteria: the risk of renal failure; the risk of cardiovascular diseases; the risk of thyroid diseases; sensitivity to cyproheptadine; intolerance side effects.
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Mashhad University of Medical Sciences
Street address
College of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd, Mashhad
City
Mashhad
Postal code
Approval date
2015-06-06, 1394/03/16
Ethics committee reference number
IR.MUMS.REC.1394.183
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
Weight
Timepoint
Baseline; second week; forth week; sixth week; eighth week
Method of measurement
In kilograms and is using the Digital Scale.
2
Description
Height
Timepoint
Baseline; second week; forth week; sixth week; eighth week
Method of measurement
Measured in meters.
3
Description
Growth rate
Timepoint
Baseline; second week; forth week; sixth week; eighth week
Method of measurement
In grams per day
4
Description
Changes in sleep by PSQI scale
Timepoint
Baseline; second week; forth week; sixth week; eighth week
Method of measurement
Using PSQI questionnaire
Secondary outcomes
1
Description
Dry mouth
Timepoint
Baseline; second week; forth week; sixth week; eighth week
Method of measurement
Questionnaire
2
Description
Swelling
Timepoint
Baseline; second week; forth week; sixth week; eighth week
Method of measurement
Questionnaire
3
Description
Sleepiness during the day
Timepoint
Baseline; second week; forth week; sixth week; eighth week
Method of measurement
Questionnaire
4
Description
Gastrointestinal side effects (diarrhea, nausea, vomiting and abdominal pain)
Timepoint
Baseline; second week; forth week; sixth week; eighth week
Method of measurement
Questionnaire
5
Description
Skin reactions
Timepoint
Baseline; second week; forth week; sixth week; eighth week
Method of measurement
Questionnaire
6
Description
Methylphenidate trade name
Timepoint
Baseline; second week; forth week; sixth week; eighth week
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention Groups: cyproheptadine, tablets 4 mg, orally, two half a tablet twice a day for 2 months
Category
Treatment - Drugs
2
Description
In the control group: placebo, tablet, taken orally, once daily for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sinai Hospital (special clinic)
Full name of responsible person
Dr. Fateme Moharrari
Street address
Sinai Hospital, Horamely street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, School of Pharmacy
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
E-Campus University of Mashhad-Iran Vakil Abad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, School of Pharmacy
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
Mashhad University of Medical Sciences - School of Pharmacy
Full name of responsible person
Faeze Kadkhoda Mezerji
Position
PharmD Student
Other areas of specialty/work
Street address
College of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3893 6424
Fax
Email
kadkhodaf891@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Of Medical Siences
Full name of responsible person
Dr. Sepide Elyasi
Position
Assistant Professor
Other areas of specialty/work
Street address
College of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3882 3255
Fax
Email
elyasis@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University Of Medical Siences - School Of Pharmacy
Full name of responsible person
Faeze Kadkhoda Mezerji
Position
PharmD Student
Other areas of specialty/work
Street address
College of Pharmacy, Ferdowsi University campus, Vakil Abad Blvd, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3893 6424
Fax
Email
kadkhodaf891@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)