The aim of the present study is to evaluate the efficacy of Bupropion on ADHD in adults through a double-blind, randomized, controlled trial. 40 outpatients, including 20-60 years old who clearly meet the DSM-IV-TR diagnostic criteria for ADHD ( based on diagnosis of a psychiatrist) will be randomly assigned to receive Bupropion tablets (300mg/day) or placebo for for 6 weeks. The primary outcome measure is the Adult ADHD Self-Report Scale (ASRS-v1.1) and Conners Adult ADHD Rating Scales–Self-Report-screening version . Patients will be assessed by a psychiatrist at baseline, as well as 3 and 6 weeks after the study started.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302201556N51
Registration date:2013-02-23, 1391/12/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-02-23, 1391/12/05
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
Tehran University of Medical Sciences
Expected recruitment start date
2013-04-03, 1392/01/14
Expected recruitment end date
2014-04-03, 1393/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of bupropion for attention deficit hyperactivity disorder in adults: a double blind and placebo controlled trial
Public title
Bupropion in the treatment of adult ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diagnosis of ADHD based on DSM-IV ; age between 20-60 Exclusion Criteria:Chronic medical disease including seizure,cardiovascular disease, CVA and organic brain disease;substance abuse or dependence during past six months;nursing or pregnant patients; history of tic disorder; receiving of any psychotropics drugs during past two weeks, mental retardation ; history of suicide attempt, psychosis or aggressiveness; receiving psychotropic drugs; receiving psycho-stimulants or atomoxetine during past three months; bipolar disorder
Age
From 20 years old to 60 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
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
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2013-02-18, 1391/11/30
Ethics committee reference number
20285
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
by Adult ADHD Self-Report Scale and Conners Adult ADHD Rating Scales–Self-Report-screening version
Secondary outcomes
empty
Intervention groups
1
Description
Tablet Bupropion(150-300 mg/day) as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Placebo for 6 weeks as control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
South Kargar Sreeet, Roozbeh Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Akbar Fotouhi
Street address
Keshvarz 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
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
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar street; Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
S.akhond@sina.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
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
South Kargar Street; Roozbeh Hospital,
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
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
South Karegar street; Roozbeh Hospital
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)