The aim of the study is to evaluate treatment clinical efficacy of Reboxitine in children and adolescents who have both attention deficit hyperactivity and anxiety disorders. This study was an open-label study in which twenty-five patients of Child and Adolescent Psychiatry Outpatient Clinic were engaged during four weeks. In this period, Reboxitine, 4 mg tablet, was prescribed twice daily. Intensity of hyperactivity and anxiety were measured by using Conners' parent questionnaire and the Hamilton Rating Scale, respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905033979N3
Registration date:2011-01-31, 1389/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-31, 1389/11/11
Registrant information
Name
Forugh Riahi
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
riahi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Reserch Devision, Ahvaz Jondishapoor Medical University
Expected recruitment start date
2009-02-19, 1387/12/01
Expected recruitment end date
2010-02-20, 1388/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Reboxetin in childhood and adolescence with ADHD and Anxiety disorder in out-patient clinic
Public title
Efficacy of Reboxetin in childhood and adolescence with ADHD and Anxiety disorder in out-patient clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ADHD and Anxeity disorder except for OCD and PTSD
Exclusion criteria: MR, presence of any medical problems, other psychotic disorder, drug or substance use
Age
From 6 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Devision, Ahvaz Jondishapoor Medical University
Street address
Golestan, Ahvaz
City
Ahvas
Postal code
15794-61357
Approval date
2009-12-20, 1388/09/29
Ethics committee reference number
7782/20/8/p
Health conditions studied
1
Description of health condition studied
Attention deficit disorder with hyperactivity and anxity
ICD-10 code
F90, F93
ICD-10 code description
Primary outcomes
1
Description
Attention deficit hyperactivity disorder
Timepoint
at the beginning (baseline) and the end of second and fourth weeks of the study.
Method of measurement
The Conner's parent rating scale–revised short version [CPRS –R(S)] scores
2
Description
Anxiety
Timepoint
At the beginning (baseline) and the end of second and fourth weeks of the study.
Method of measurement
The Hamilton anxiety rating scale scores
Secondary outcomes
1
Description
Rate of diastolic and systolic blood pressure
Timepoint
at the beginning (baseline) and the end of second and fourth weeks of the study.
Method of measurement
Assessment of peripheral blood pressure with blood pressure monitor
2
Description
Rate of side effects
Timepoint
at the beginning (baseline) and the end of second and fourth weeks of the study.
Method of measurement
based on Pharmaceutical list
3
Description
Pulse rate
Timepoint
at the beginning (baseline) and the end of second and fourth weeks of the study.
Method of measurement
Assessment of Peripheral pulse rate
Intervention groups
1
Description
Reboxitine 4 mg tablet twice daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Child and Adolecent Psychiatry Clinic, Golestan Hospital
Full name of responsible person
Forugh Riahi
Street address
Psychiatry Group, Golestan Hospital, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Reserch Devision, Ahvaz Jondishapoor Medical University
Full name of responsible person
Makhmal Zade Sharif
Street address
Ahvaz Jondishapoor Medical University, Golestan street
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Reserch Devision, Ahvaz Jondishapoor Medical University
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
Ahvaz Jondishapoor Medical University
Full name of responsible person
Forugh Riahi
Position
Child Psychiatrist, Assistant Professor
Other areas of specialty/work
Street address
Psychiatry Group, Golestan Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1374 3038
Fax
+98 61 1374 3038
Email
riahi13@gmail.com ,riahi-f@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapoor Medical University
Full name of responsible person
Forugh Riahi
Position
child psychiatrist -Assistant Professor
Other areas of specialty/work
Street address
Psychiatry Group, Golestan Hospital, Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1374 3038
Fax
Email
riahi13@gmail.com ,riahi-f@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jondishapoor Medical University
Full name of responsible person
Forugh Riahi
Position
Child Psychiatrist- Assistant Professor
Other areas of specialty/work
Street address
Forugh Riahi
City
Psychiatry Group, Golestan Hospital, Ahvaz
Postal code
Phone
+98 61 1374 3038
Fax
Email
riahi13@gmail.comriahi-f@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)