The aim of the present study is to evaluate the efficacy of Omega 3 on ADHD in children through a double-blind, randomized, controlled trial. 66 outpatients, including 6-12 years old who clearly meet the DSM-IV-TR diagnostic criteria for ADHD( based on duiagnosis of a child psychiatrist) will be randomly assigned to receive Omega 3 (EPA 180mg, DHA 120mg BID) and methylphenidate (5 to 30 mg per day) or Methylphenidate (5 to 30 mg per day) and placebo for 8 weeks. The primary outcome measure is the Coner's and Parent ADHD Rating Scale. Patients will be assessed by a child psychiatrist at baseline, 2,4 and 8 weeks after the medication started. Side effects were also rated by side effects questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060128182N2
Registration date:2017-01-23, 1395/11/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-23, 1395/11/04
Registrant information
Name
Soleiman Mohammadzadeh
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 2168
Email address
dr.mohammadzadeh86@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of omega-3 supplement as an adjunctive therapy in children with attention deficit hyperactivity disorder
Public title
omega-3 supplement in attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diagnosis of ADHD based on DSMIV age between 6-12 Exclusion Criteria: receiving of omega3 suplement during past 6 months; presence of seizures; mental retardation; having any psychiatric disorders
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Science, Pasdaran Street
Baseline, second, fourth and eighth weeks after intervention
Method of measurement
Conner's and ADHD Rating Scales
2
Description
Improvement in Impulsivity symptoms
Timepoint
Baseline, third and sixth weeks after intervention
Method of measurement
Conner's and ADHD Rating Scales–Self-Report
3
Description
Improvement in hyperactivity symptome
Timepoint
Baseline, third and sixth weeks after intervention
Method of measurement
Conner's and ADHD Rating Scales–Self-Report
Secondary outcomes
1
Description
severity of ADHD symptoms
Timepoint
Baseline, second, fourth and eighth weeks after intervention
Method of measurement
ADHD Rating Scales, CGI
2
Description
side effect
Timepoint
second, fourth and eighth weeks after intervention
Method of measurement
Side effects quesionnaire
Intervention groups
1
Description
One group of patients are randomly assigned to receive methylphenidate in the intervention group. Methylphenidate 10 mg is prescribed for the first week, a daily tablet (half tablet in morning at 8 o'clock and half tablet at 16 o'clock); in the second week, two tablets are daily prescribed (one in the morning at 8 o'clock, one at 16 o'clock); if the weight is above 30 pounds, 3 tablets will be daily prescribed in the second week (one and a half tablet each morning at 8 o'clock, one and a half tablet at 16 o'clock). Therapeutic dosage of omega3 is prescribed a tablet daily for the first week ( one tablet in the morning at 8 o'clock) and 2 tablets are daily prescribed in the second week (one tablet in the morning at 8 o'clock, one tablet at 16 o'clock).
Category
Treatment - Drugs
2
Description
One group of patients are randomly assigned to receive methylphenidate in the control group. Methylphenidate 10 mg is prescribed for the first week, a daily tablet (half tablet in morning at 8 o'clock and half tablet at 16 o'clock); in the second week, two tablets are daily prescribed (one in the morning at 8 o'clock, one at 16 o'clock); if the weight is above 30 pounds, 3 tablets will be daily prescribed in the second week (one and a half tablet each morning at 8 o'clock, one and a half tablet at 16 o'clock). Therapeutic dosage of placebo is prescribed a tablet daily for the first week ( one cap in the morning at 8 o'clock) and 2 cap are daily prescribed in the second week (one cap in the morning at 8 o'clock, one cap at 16 o'clock).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical, Educational and Terapeutic Center of Besat Hospital
Full name of responsible person
Soleiman Mohammadzadeh
Street address
Medical, Educational and Terapeutic Center of Besat Hospital, Keshawarz Street
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Farzin Rezaei
Street address
Kurdistan University of Medical Sciences, Pasdaran Street
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Soleiman Mohammadzadeh
Position
Child and Adolescent Psychiatry
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, Pasdaran Street
City
Sanandaj
Postal code
Phone
00
Fax
Email
dr.mohammadzadeh86@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Soleiman Mohammadzadeh
Position
Child and Adolescent Psychiatry
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, Pasdaran Street
City
Sanandaj
Postal code
Phone
00
Fax
Email
dr.mohammadzadeh86@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Soleiman Mohammadzadeh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 918 873 3986
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)