Protocol summary

Summary
The aim of the present study is to evaluate the efficacy of Bupropion on ADHD in children and adolescents through a double-blind, randomized, controlled trial. 40 outpatients, including 6-17 years old who clearly meet the DSM-IV-TR diagnostic criteria for ADHD will be randomly assigned to receive Bupropion tablets (200 mg/day for those who are <30 Kg and 300 mg/day for those who are >30 Kg) or methylphenidate (20 mg/day for those who are <30 Kg and 30 mg/day for those who are >30 Kg) for 6 weeks. The primary outcome measure is the Teacher and Parent ADHD Rating Scale- IV. Patients will be assessed by a psychiatrist at baseline, as well as 3 and 6 weeks after the medication started.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012021556N18
Registration date: 2010-12-04, 1389/09/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-12-04, 1389/09/13
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
1-Tehran University of Medical Sciences 2-Kurdistan University of Medical Sciences-Sanandaj-Iran
Expected recruitment start date
2010-05-14, 1389/02/24
Expected recruitment end date
2011-11-14, 1390/08/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of bupropion and ritaline in the treatment of children with ADHD: a double blind trial
Public title
comparison of bupropion and ritaline in the treatment of children with ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diagnosis of ADHD based on DSM-IV, age between 6-17 Exclusion Criteria: receiving of any psychotropics drugs during past two weeks, presence of any psychiatric disorders or mental retardation (I.Q. <70) except for ODD, History of Allergy to Bupropion, presence of any medical problem including cardiovascular dieseases, presence of uncontrolled seizures, systolic blood pressure>125, resting pulse rate <60/minute or >115/minute, zinc deficiency, lead intoxication
Age
From 6 years old to 17 years old
Gender
Both
Phase
2-3
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
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2010-04-14, 1389/01/25
Ethics committee reference number
9745

Health conditions studied

1

Description of health condition studied
Disturbance of activity and attention
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention

Primary outcomes

1

Description
Severity of ADHD
Timepoint
Week 0 (before treatment) and Weeks 3 and 6 after treatment
Method of measurement
Teacher and Parent ADHD Rating Scale

Secondary outcomes

empty

Intervention groups

1

Description
Tablet Bupropion(200 to 300 mg/day) as intervention group for 6 weeks
Category
Treatment - Drugs

2

Description
Tablet Ritalin 20-30 mg/kg/day for 6 weeks as control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Mohammad Reza Mohhamadi
Street address
Roozbeh Hospital
City
Tehran

2

Recruitment center
Name of recruitment center
Qhods Hospital- Kurdistan University of Medical Sciences
Full name of responsible person
Dr. Farzin Rezaei
Street address
Pasdaran Blvd- Qhods hospital - Sanandaj
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
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
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Ataollah Heydari
Street address
Pasdaran Blvd-Kurdistan university of Medical Sciences-Deputy of research- Sanandaj
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
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital-South Karegar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital -south Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
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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