The efficacy of Venlafaxine in comparison with placebo in the treatment of adult with
attention deficit hyperactivity disorder: A double blind randomized clinical trial
The propose is to study the efficacy of Venlafaxine in the treatment of adult attention-deficit hyperactivity disorder (ADHD). Forty subjects between 18-45 years who clearly meet diagnostic criteria for adult ADHD, from parents and siblings of children with ADHD who are referred to child and adolescent psychiatric clinic of RAZI hospital will assign. Inclusion criteria: confirm of symptoms of ADHD in childhood & diagnosis of ADHD on clinical psychiatric interview. Exclusion criteria: any other psychiatric disorder and physical illness. This is a double blind randomized clinical trial study. Subjects receive either Venlafaxine or placebo randomly for 6 week. Venlafaxine will titrate up during the trial according to the following Schedule: week 1, 2; 75mg/day (once daily), week 3, 4 150mg/day (twice daily) and week 5, 6; 225mg/day (thrice daily). Patients will assess at baseline, 14, 28 and 42 days after the medication start with Adult Conner's questionnaires for assessing severity of symptoms of ADHD. Side effects will systematically record throughout the study and will assess using a checklist that comprises side effects by psychiatrist on days 14, 28 and 42.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808122660N1
Registration date:2010-01-25, 1388/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-01-25, 1388/11/05
Registrant information
Name
Shahrokh Amiri Aziza Abad
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1380 4486
Email address
amirish@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Venlafaxine in comparison with placebo in the treatment of adult with
attention deficit hyperactivity disorder: A double blind randomized clinical trial
Public title
Use of Venlafaxine in the treatment of adult attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Age between 18-45 year 2. Having Adult attention deficit hyperactivity disorder (ADHD) according to the judgment of two psychiatrists 3. Confirm of ADHD symptoms at childhood period.
Exclusion criteria: 1. Evidence of mental retardation ( IQ<70 based on clinical judgment ) 2. Other psychiatric comorbidity 3. Any significant chronic medical condition, including organic brain disorder and seizure 4. Current abuse or dependence on substance within 6 months 5. Pregnant and lactating women . 6. use any psychiatirc drugs in recent two weeks
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
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
Vice Chancellor for research of Tabriz University of Medical Sciences