The purpose of this double blind clinical trial is to compare efficacy and side effects of Duloxetine and Ritalin in ADHD patients. In this study, 40 patients in the age range of 11-18 with ADHD will be randomly assigned into intervention or control groups. The patients in the intervention group will receive Duloxetine and control group will receive Ritalin. CANERS test for parents (summarized and edited format) and ADHD rating scale for parents and teacher will be performed before treatment and after 2, 4, 6 and 8 weeks and side effect questionnaire will be administered in 2, 4, 6 and 8 weeks after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110127462N2
Registration date:2011-10-19, 1390/07/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-10-19, 1390/07/27
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
2011-10-23, 1390/08/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and complication of Duloxetine in attention deficeit –hyperactivity disorder (ADHD) and comparison with Ritalin
Public title
Efficacy and complication of Duloxetine in attention deficeit –hyperactivity disorder (ADHD) and comparison with Ritalin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnostic criteria based on DSM IV for children with ADHD, age range 11-18, no consumption of any effective psychological drugs in past two week
Exclusion criteria: mental retardation, any other psychological disorders except for ODD, history of allergy to Duloxetine, serious medical conditions such as heart disease, uncontrolled convulsive disorder, systolic pressure upper than 125 mmhg or resting pulse less than 60 or more than 115 bit/m
Age
From 11 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not 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
Qods street, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2011-06-12, 1390/03/22
Ethics committee reference number
11148
Health conditions studied
1
Description of health condition studied
attention deficiency hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
attention deficiency hyperactivity disorder
Timepoint
Baseline, 2, 4, 6, 8 weeks after treatment
Method of measurement
CANERS test for parents (summerized and edited format) and ADHD rating scale for parents and teacher
Secondary outcomes
1
Description
drugs side effects
Timepoint
Baseline, 2,4,6,8 weeks after treatment
Method of measurement
side effect questionnaire
Intervention groups
1
Description
Intervention group: Duloxetine 1/4 capsule in the first week, 1/2 capsule in second week, 3/4 capsule in third week and 1 capsule in fourth week
Category
Treatment - Drugs
2
Description
Control group: according to Ritalin dosage 0.4-1.3 mg/kg, Ritalin 1 capsule for the first week (1/2 in the morning and 1/2 at noon), 2 capsule for the second week (1 capsule in the morning and 1 capsule at noon); if the weight of patient is more than 30 kg, 3 capsule will be daily prescribed for the third week (1 capsule in the morning and 1 capsule at noon and 1 capsule in the afternoon)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry and Psychology Research Center, Roozbeh Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mrs Moamaie
Street address
Qods street, Keshavarz Blvd, 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
Psychiatry research center, Tehran University of Medical Sciences
Full name of responsible person
Rozita Jalilian
Position
MD student
Other areas of specialty/work
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
rozita_jalilian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Psychiatry and Psychology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Mohammadi
Position
MD
Other areas of specialty/work
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN.
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
pprct@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Psychiatry and Psychology Research Center
Full name of responsible person
Maryam Salmanian
Position
MS/Researcher
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
pprct@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)