Effect of ondansetron combination therapy with risperidone in children with autism spectrum disorder in a randomized, double-blind, placebo-controlled clinical trial
The effect of ondansetron combination therapy with risperidone in children and adolescents aged 5-17 years with autism spectrum disorder.
Design
In this study, 50 patients with autism spectrum disorder who were being treated with the standard drug Risperidone will be randomly assigned (using Replacement randomization) into two groups: Risperidone and ondansetron , Risperidone, and placebo.
The study is double blinded and controlled by placebo, and the phase of this study will be 3.
Settings and conduct
50 patients with autism spectrum disorder at Roozbeh Hospital are being randomly treated with an ondanseTron supplement with placebo control. In this study, researchers and patients will be blinded and will not know the type of medication used.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Having autism spectrum disorder diagnostic criteria based on DSM-5 clinical interview and semi-structured interview(Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) Present and Lifetime Version) K-SADS-PL
2- Age 15-6 years
3. Written consent by the patient's guardian, along with patient consent, to participate in the study.
Exclusion criteria:
1. Any active physical illness
2. There is a psychiatric diagnosis other than mental retardation,
3 - taking any medication affecting mental status other than risperidone at least two weeks prior to the study,
4. A history of ondansetron allergy
5. Liver or heart or neurologic or associated kidney disease
Intervention groups
Intervention group: Patients with autism spectrum disorder are treated with risperidone and endanesterone for 8 weeks.
Control group: Patients with autism spectrum disorder are treated with risperidone and placebo for 8 weeks.
Main outcome variables
Symptoms of Autism Spectrum Disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200317046801N2
Registration date:2020-04-13, 1399/01/25
Registration timing:prospective
Last update:2020-04-13, 1399/01/25
Update count:0
Registration date
2020-04-13, 1399/01/25
Registrant information
Name
Rahim Badrfam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9151
Email address
rbadrfam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-11, 1399/06/21
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ondansetron combination therapy with risperidone in children with autism spectrum disorder in a randomized, double-blind, placebo-controlled clinical trial
Public title
The effect of ondansetron on autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria:1-Having criteria for diagnosing autism spectrum disorder based on DSM-5 clinical interview and semi-structured K-SADS interview -.
6 -15years old
-To participate in the study with the written consent of the patient's guardian and with the patient's consent
Exclusion criteria:
Any active physical illness
There is a psychiatric diagnosis other than mental retardation
- taking any medication affecting mental status other than risperidone at least two weeks prior to the study,
A history of ondansetron allergy
Liver or heart disease or neurological or associated kidney disease
Causing any drug side effects
The patient's or guardian's unwillingness to continue to be involved in the research project for any reason
Age
From 5 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, one of the simple (unlimited) randomization methods called Replacement randomization is used. The randomization program is repeated until the desired balance is reached, ie 25 people in each control group and intervention is achieved.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researchers, who are the principal investigators, as well as the patients studied and those responsible for taking care of the patients, are unaware of any prescription medication. The ondansetron and placebo medication is completely in the same form (in terms of color, odor and appearance) and the researchers, patients and caregivers have no knowledge of the type of prescription drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
North Kargar Ave.Lashgar Road.Rozbeh Hospital.
City
Tehran
Province
Tehran
Postal code
1333715914
Approval date
2020-01-22, 1398/11/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.802
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Symptoms of Autism Spectrum Disorder
Timepoint
Baseline and weeks 4and 8
Method of measurement
Childhood Autism Rating Scale (CARS)
2
Description
Relationship and Behavior
Timepoint
Baseline and weeks 4and 8
Method of measurement
Aberrant Behavior Checklist-Community (ABC-C)
3
Description
Self-concept
Timepoint
Baseline and weeks 4and 8
Method of measurement
Self- Conception Questionnaire
4
Description
Psychiatric diagnosis of autism disorder
Timepoint
Baseline and weeks 4and 8
Method of measurement
kiddie-sads-present and lifetime version (k-sads-pl)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with autism disorder will be treated with combination of risperidone with ondansetron for 8 weeks. Over 40kg and in case of ondansetron is 05 mg / kg / day Dr. Farhad Mostofi's pharmacy has also contributed to this research project in the field of drug and placebo preparation.
Category
Treatment - Drugs
2
Description
Control group: Patients with autism disorder will be treated with a combination of risperidone and placebo for 8 weeks. Above 40 kg and in placebo is 05 mg / kg / day. Dr. Farhad Mostofi's pharmacy has also contributed to this research project in the field of medicine and placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rozbeh Hospital.
Full name of responsible person
Rahim Badrfam
Street address
North Kargar Ave.Lashgar Road.Rozbeh Hospital.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
rbadrfam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Tehran University of Medical Sciences
Street address
Sixth Floor, Qods Ave., Keshavarz Blvd.Vice Chancellor for Research and Technology,
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Rshim Badrfam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
North Kargar Ave.Lashgar Road.Rozbeh Hospital.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
rbadrfam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Tehranidoost
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
North Kargar Ave.Lashgar Road.Rozbeh Hospital.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
tehranid@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rahim Badrfam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
North Kargar Ave.Lashgar Road.Rozbeh Hospital.
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
rbadrfam@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Once the article is published, all the information and data and results will be available to everyone.