The goal of this trial is to examine the efficacy and safety of Duloxetine vs Methylphenidate in the treatment of adolescents with ADHD. 30 patients age between 11 to 18 years will be included. Participants will be randomly allocated to receive Duloxetine (30 mg/day and will be titrated up to 60 mg/day after a week) or Methylphenidate (10 mg/day and will be increased to 40 mg/day weekly according to the patient tolerance) for 6 weeks. Participants will be evaluated at baseline for ADHD symptom severity and every two weeks and the end of sixth week for ADHD symptom severity and drug side effects. Comorbidities will be assessed using K-SADS-PL semi-structured interview at the baseline.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810193029N1
Registration date:2010-03-01, 1388/12/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-03-01, 1388/12/10
Registrant information
Name
Javad Mahmoudi Gharai
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9151
Email address
jmahmoudi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-12-01, 1388/09/10
Expected recruitment end date
2010-03-30, 1389/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Duloxetine vs Methylphenidate in adolescents with ADHD: A randomized trial
Public title
Duloxetine in ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of ADHD according to DSM-IV-TR Criteria, age range of 11 to 18 years
Exclusion criteria: Presence of mental retardation, cardiac problems, known contraindications to study drugs, Comorbidity of severe major depression, conduct disorder, bipolar or psychotic disorders, epilepsy taking anticonvulsants at the time of enrollment and during the trial, pregnancy or lactation, refusal to participate
Age
From 11 years old to 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 and Health Services
Street address
Qods Ave, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2009-12-01, 1388/09/10
Ethics committee reference number
88-02-30-8700
Health conditions studied
1
Description of health condition studied
ADHD
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
ADHD severity of symptoms
Timepoint
Baseline, Every 2 weeks, End point
Method of measurement
Conner's and ADHD rating Scale
Secondary outcomes
1
Description
Drug side effects
Timepoint
every 2 weeks and end point
Method of measurement
Questionnaire
Intervention groups
1
Description
Duloxetine, 30-60 mg/day, starting dose 30 mg/day for 1 week and 60 mg/day for the following 5 weeks
Category
Treatment - Drugs
2
Description
Methylphenidate, starting dose: 10 mg/ day divided in two doses for 1 week and 20, 30 and 40 mg/day divided in 3 doses in weeks 2, 3 and 4 respectively according to the patient tolerance and continue in weeks 5 and 6
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center
Full name of responsible person
Javad Mahmoudi Gharaei
Street address
Dr Gharib Ave
City
Tehran
2
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Javad Mahmoudi-Gharaei
Street address
South Kargar Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health services
Full name of responsible person
Mrs, Khalili
Street address
Qods Ave, Keshavarz Blvd.
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 and Health services
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
Dr. Javad Mahmoudi-Gharaei
Position
Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Psychiatry and Psychology research Center, Roozbeh Hospital, South Kargar Ave.,
City
Tehran
Postal code
Phone
+98 912 226 2590
Fax
Email
jmahmoudi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Javad Mahmoudi-Gharaei
Position
Assistant professor
Other areas of specialty/work
Street address
Roozbeh hospital, Psychiatry and psychology research center, South kargar Ave.
City
Tehran
Postal code
Phone
+98 912 226 2590
Fax
jmahmoudi@razi.tums.ac.ir
Email
jmahmoudi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Javad Mahmoudi-Gharaei
Position
Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar Ave
City
Tehran
Postal code
Phone
+98 21 5541 9151
Fax
Email
jmahmoudi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)