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A double-blind, placebo-controlled study on the efficacy of risperidone adjunctive to methylphenidate in patients with ADHD

Protocol summary

Summary
This is a randomized, double-blind clinical trial to evaluate the efficacy of add on Risperidone to methylphenidate in ADHD. In this study 80 patients, referred to psychiatry ward of Farshchian Hospital will be enrolled in the study with consent inform ,who have been diagnosed as ADHD based on DSM-IV TR and Conner's rating scale ,their age is between 6 to 12years with IQ> 70 and have no known systemic or psychiatric disease . The patients will be divided into two groups based on randomized blocks. The case group will receive methylphenidate with maximum dose of 30 mg per day with risperidone witn maximum dose of 1 mg per day and the control group will receive methylphenidate with maximum dose of 30 mg per day along with placebo for 8 weeks. Prior to start the treatment, they will undergo ALT, AST, LDH, CPK, LDL, HDL, CHOL, and TG tests. Before the treatment and the intervals of 2,4,6and 8weeks after the treatment, the patients wiil be assessed through Conner's rating Scale and Clinical Global Rating scale and finally the improvement rate of the both groups compared to each other. .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201211051743N10
Registration date: 2013-01-26, 1391/11/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-01-26, 1391/11/07
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 4184
Email address
haghighi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double-blind, placebo-controlled study on the efficacy of risperidone adjunctive to methylphenidate in patients with ADHD
Public title
efficacy of risperidone in ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diagnosed as ADHD according to DSM-IV TR and conner's scale; Age between 6 to12years; No other psychiatric disorders along with ADHD; No other debilitating physical illness along with ADHD; IQ>70 Exclusion Criteria: Severe drug complication during the study; abnormal labratory tests (BC,NA,K,BS,BUN,CR,TSH,AST,ALT,PRL,TOT CHOL,LDL CHOL,HDL,CHOL,TG).
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Hamadan University of Medical Sciences
Street address
Farshchian Hospital
City
Hamadan
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
د-پ-16-35-9-2552

Health conditions studied

1

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

Primary outcomes

1

Description
improvement ADHD symptoms
Timepoint
first of the study and after 2nd,4th,6th and 8th week of the study.
Method of measurement
Clinical Global Impression Scale and conner`s parents rating scale for ADHD

Secondary outcomes

1

Description
drug side effects
Timepoint
after 2nd,4th,6th and 8th week of the study
Method of measurement
Clinical Global Impression Scale

Intervention groups

1

Description
methylphenudate with maximum dose of 30 mg per day and placebo for 8 weeks
Category
Treatment - Drugs

2

Description
methylphenudate with maximum dose of 30 mg per day and risperidone with maximum dose of 1 mg per day for 8 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
shahrokh akbarian
Street address
Farshchian Hospital
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science
Full name of responsible person
dr.mohammad Ahmadpanah
Street address
Farshchian Hospital
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science
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
Research center for behavioral disorders and substance abuse, Hamadan University of Medical Science
Full name of responsible person
shahrokh akbarian
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
Phone
+98 81 1828 5015
Fax
Email
shahrokhakbarian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Dr. Leila Jahangard
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
65168-4-8741
Phone
+98 81 1828 5015
Fax
Email
jahangard_li_ps@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
shahrokh akbarian
Position
Resident of psychiatry
Other areas of specialty/work
Street address
Farshchian Hospital
City
Hamadan
Postal code
65168-4-8741
Phone
+98 81 1828 5015
Fax
+98 82 85015
Email
shahrokhakbarian@yahoo.com
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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