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Evaluation and comparison of plasma level of brain-derived neurotrophic factor before and after treatment with methylphenidate in children and adolescent with ADHD.

Protocol summary

Summary
The aim of this study is comparison of plasma level of brain-derived neurotrophic factor before and after treatment with methylphenidate in children and adolescent with ADHD. This is a before-after study without placebo. Samples consist of 30 children and adolescents suffering from ADHD who referring to the SHAFA hospital in Rasht. Sampling is based on DSM-IV oriented clinical interview and hemi-structured inventory of K-SADS. Inclusion criteria: age below 18, absence of any other axis I diagnosis, absence of any neurological disorder and use of psychotropic drug within the last month, IQ>70. Exclusion criteria: drug discontinue due to side effects, augmentation of any other psychotropic medication, occurring of any major neurological and psychiatric disorder, acute and febrile disease within current 2weeks. Plasma level of BDNF will be measured according to the kit instructions. After 4 weeks dose adjustment, patients will undergo treatment with methylphenidate more 6 weeks. Ultimately symptom severity and plasma Level of BDNF will be measured again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108067237N1
Registration date: 2011-08-10, 1390/05/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-08-10, 1390/05/19
Registrant information
Name
Maryam Kousha
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 1163
Email address
m-kousha@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research- Guilan University of Medical Sciences- Iran
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of plasma level of brain-derived neurotrophic factor before and after treatment with methylphenidate in children and adolescent with ADHD.
Public title
Evaluation of methylphenidate effect on brain growth factor.
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: age below 18; absence of any other axis I diagnosis; absence of any neurological disorder; use of psychothropic drug within the last month; IQ>70. Exclusion criteria: drug discontinue due to side effects(tics, hallucinations, depressed mood, OCD, ...); augmentation of any other psychotropic medication; occuring of any major neurological and psychiatric disorder (eg, depression, bipolare, psychotic disorders); acute and febral disease within current 2weeks.
Age
From 3 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)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Befor-After study

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Namjoo Street, Rasht
City
Rasht
Postal code
65385-41446
Approval date
2011-07-20, 1390/04/29
Ethics committee reference number
1900189601

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
BDNF(Brain-derived neurotrophic factor) plasma level
Timepoint
Before treatment, 10 weeks after treatment
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
6 weeks treatment with effective dosage of methylphenidate
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Dr Maryam Kousha
Street address
Shafa hospital, Heshmat square, rasht
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Abdorrasool Sobhani
Street address
Namjoo street- Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr Maryam Kousha
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Shafa hospital, Heshmat square, rasht
City
Rasht
Postal code
Phone
+98 13 1666 6268
Fax
Email
m-kousha@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Maryam Kousha
Position
Assistant professor
Other areas of specialty/work
Street address
Shafa hospital, Heshmat square, Rasht
City
Rasht
Postal code
Phone
+98 13 1666 6268
Fax
Email
m-kousha@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr Maryam Kousha
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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