The aim of this study was to evaluate the effect of Buspirone on hyperactivity disorder in children.
Design
study was conducted on 50 patients with ADHD who were diagnosed by a child and adolescent psychiatrist which were eligible for inclusion in the study. Participants were randomly divided into two intervention groups and control group and each participant was assigned a code. For 25 patients in group one, Ritalin and Buspirone tablets, and for 25 patients in the second group, Ritalin and Placebo are given.
Settings and conduct
The research consisted of 50 patients with ADHD who referred to the Sanandaj Besat Hospital. Patients were randomly divided into two intervention groups and control group. The results of intervention at the beginning of the research and the second, fourth and eighth weeks are measured by the questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Diagnosis of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5),Age between 6 -12 years Exclusion criteria:1- Intellectual disability based on clinical suspicious 2-presence of uncontrolled seizure
Intervention groups
Intervention group: A group of randomly selected patients received methylphenidate tablets (10 mg) for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 PM) and the second week (half the tablet at 8:00 am and half the tablet at 4:00 PM). ) and from the third week afterwards (one tablet at 8:00 am and one tablet at 4:00 PM) Along with Buspirone powder 5 milligram for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 pm) and the second week (half the tablet at 8:00 am and half the tablet at 4:00 pm and afterwards the third week (five milligram at 8:00 am and five milligram at 4:00 pm).
Main outcome variables
Treatment for ADHD patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160530028182N7
Registration date:2019-11-03, 1398/08/12
Registration timing:registered_while_recruiting
Last update:2019-11-03, 1398/08/12
Update count:0
Registration date
2019-11-03, 1398/08/12
Registrant information
Name
Soleiman Mohammadzadeh
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 2168
Email address
dr.mohammadzadeh86@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Methylphenidate and Buspirone as Adjuant therapy in children with ADHD treated by Methylphenidate mono therapy
Public title
Effect of Buspirone in ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 6 -12 years
Diagnosis of ADHD and ODD based on DSM5
without effective medication taking on mental status at least 2 weeks before the study
Exclusion criteria:
Intelectual disability based on clinical suspicious
presence of uncontroled siezure
Drug side effects and hypersensivity
Recieving of any other drugs
History of psychological disorder except for ADHD and ODD
presence of medical deasese such as cardiac deaseses
Age
From 6 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Individual based-simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug is prepared by the pharmacist and in coding packages which only the pharmacist is aware of its coding and deliverd by researcher to the patient. Neither the investigator, nor the patient nor the analyst, knows the contents of the drug packages and the way they are coded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran street
City
ُSanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2017-07-24, 1396/05/02
Ethics committee reference number
IR.MUK.REC.1395.135
Health conditions studied
1
Description of health condition studied
Attention deficit/hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Clinical Profile of illness reported by parents
Timepoint
Baselin , second,fourth and eighth weeks after intervention
Method of measurement
Canner's and ADHD Rating scales
2
Description
symptoms severity reported by parents
Timepoint
Baselin , second ,fourth and eighth weeks after intervention
Method of measurement
ADHD Rating scale and CGI
3
Description
efficacy of treatment
Timepoint
Baselin , second ,fourth and eighth weeks after intervention
Method of measurement
The Clinical Global Impressions (CGI) Scale used to rate the symptoms change over time, and efficacy of medication, taking into account the patient’s clinical condition by clinicians.
Secondary outcomes
1
Description
Drug side effects
Timepoint
Second, fourth and eighth weeks after intervention
Method of measurement
checklist by clinical interview and exam
Intervention groups
1
Description
Intervention group: A group of randomly selected patients received methylphenidate tablets (10 mg) for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 PM) and the second week (half the tablet at 8:00 am and half the tablet at 4:00 PM). ) and from the third week afterwards (one tablet at 8:00 am and one tablet at 4:00 PM) with a capsule containing Buspirone powder for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 pm) and the second week (half the tablet at 8:00 am andhalf the tablet at 4:00 pm) and after the third week (one tablet at 8:00 am and one tablet at 4:00 pm).
Category
Treatment - Drugs
2
Description
Control group: A group of randomly selected patients received methylphenidate tablets (10 mg) for the first week (one quarter of the tablet at 8:00 am and one quarter of the tablet at 4:00 PM) and the second week (half the tablet at 8:00 am and half the tablet at 4:00 PM). ) and from the third week afterwards (one tablet at 8:00 am and one tablet at 4:00 PM) with a capsule containing placebo powder for the first week (1.25 mg at 8:00 am and 1.25 mg at 4:00 pm) and the second week (2.5 mg at 8:00 am and 2.5 mg at 4:00 pm) and after the third week (5 mg at 8:00 am and 5 mg at 4:00 pm).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical, Educational and Terapeutic Center of Besat Hospital
Full name of responsible person
Dr.Soleiman Mohammadzadeh
Street address
Medical, Educational and Terapeutic Center of Besat Hospital, Keshawarz Street
City
Sanandaj
Province
Kurdistan
Postal code
6619667761
Phone
+98 87 3328 2004
Email
dr.mohammadzadeh86@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Farzin Rezaie
Street address
Pasdaran street
City
Sanandaj
Province
Kurdistan
Postal code
66614713446
Phone
+98 87 3366 4653
Email
frrezaie@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr.Soleiman Mohammadzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran street Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66614713446
Phone
+98 87 3366 4653
Email
dr.mohammadzadeh86@muk.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr.Soleiman Mohammadzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran street Sanandaj
City
ُSanandaj
Province
Kurdistan
Postal code
66614713446
Phone
+98 87 3366 4653
Email
dr.mohammadzadeh86@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr.Soleiman Mohammadzadeh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Pasdaran street Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66614713446
Phone
+98 87 3366 4653
Email
dr.mohammadzadeh86@muk.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available