Evaluating the efficacy of adding N-Acetyl cysteine to risperidone treatment regimen in patients with autism spectrum disorder
Design
This study is a phase 3 clinical trial with a control group, with parallel, double-blind, randomized. Total of 66 ASD children who were selected from the population of by convenience sampling method and eligable patients will enter the study after a diagnostic interview.
Samples will be randomly assigned to each group and divided into two groups with 33 individuals.
Settings and conduct
Research subjects included patients with ASD who referred to pediatric psychiatric clinics at Dr. Sheikh and Ibn Sina hospitals and private practice.
One group is treated with risperidone and placebo tablets and the other group is treated with risperidone and n-acetylcysteine tablets. The maximum dose used is respridone 1.5 mg daily and n-acetylcysteine 600 mg daily. The study will be evaluated by a CARS and CGI questionnaire during the study. The treating psychiatrist, psychiatric assistant evaluating the results, and the patient are unaware of the type of drug administered
Participants/Inclusion and exclusion criteria
ASD patients aging between 3 and 12 who their parents take the informed consent will enter the study. These children will not have any psychiatric or organic illness and have IQ score greater than 50; patients who their parents refuse to corporate for any reason, using any other psychiatric drugs except risperidone or having any drug side effects which will confer with study results will be excluded.
Intervention groups
In addition to risperidone therapy provided for study participants, the intervention group will receive N-acetylcysteine (600 mg) for 10 weeks.
Main outcome variables
Regimens in patients with autism spectrum disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190714044199N1
Registration date:2019-11-10, 1398/08/19
Registration timing:registered_while_recruiting
Last update:2019-11-10, 1398/08/19
Update count:0
Registration date
2019-11-10, 1398/08/19
Registrant information
Name
Parisa Pakravan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3661 6621
Email address
pakravanp961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of adding N-Acetyl cysteine to risperidone treatment regimen in patients with autism spectrum disorder
Public title
Efficacy of N-Acetyl cysteine in patients with autism spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Autism spectrum disorder (ASD) patients aging between 3 to 12
Having parental informed consent
IQ score greater than 50 based on Wildland Test
Receiving risperidone therapy for at least one month
Lack of clear organic disease (based on family history and medical records) Clear organic causes include visual and hearing impairment, seizures, trauma cycles, chronic or acute medical disorder, and brain dysfunction.
Psychiatric disorders including Toure's syndrome, Fragile X syndrome, schizophrenia, Attension deficit hyperactivity disorder (ADHD) based on structured psychiatric interview conducted by pediatric psychiatrist
Exclusion criteria:
If the parents do not cooperate for any reason after entering the study 2- 3-
Use of any psychotropic drugs other than risperidone
Any unbearable or life-threatening drug side effect or any other illness that requires medication which may interfere with results of this study.
Age
From 3 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Sixty-six ASD children will be selected by convenience sampling population. Eligible patients will be included in the diagnostic interview. Samples will be randomly assigned to each group and divided into two groups of 33 individuals.
Blinding (investigator's opinion)
Double blinded
Blinding description
The psychiatrist, the psychiatric assistant evaluating the results, and the patient are unaware of the type of medication prescribed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
Ethics Committee on Research, Quraishi Building,daneshgah str, Mashhad, Iran.
City
mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2019-06-22, 1398/04/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.212
Health conditions studied
1
Description of health condition studied
Autism spectrum disorder
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
Severity of ASD was evaluated by CARS questionnaire
Timepoint
Baseline, 5 and 10 weeks after baseline
Method of measurement
CARS questionnaires
2
Description
Severity, drug response and drug adverse effects was evaluated by CGI questionnaire
Timepoint
Baseline, 5 and 10 weeks after baseline
Method of measurement
CGI questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Case group: 33 patients treated with risperidone tablets with a maximum dose of 1.5 mg daily and n-acetylcysteine tablets 600 mg daily
Category
Treatment - Drugs
2
Description
Control group: 33 patients treated with risperidone tablets with a maximum dose of 1.5 mg daily and placebo pills daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric psychiatric clinics of Doctor Sheikh and Ibn Sina Hospitals and private psychiatric clinic
Full name of responsible person
Hebrani Paria
Street address
Ibne-sina Hospital, Buali square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
hebranip@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical Science University of Mashhad
Full name of responsible person
Hebrani Paria
Street address
Ibne-sina hospitalو Buali square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
hebranip@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Science University of Mashhad
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
Mashhad University of Medical Sciences
Full name of responsible person
Pakravan Parisa
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibne-sina hospital, Buali square, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
pakravanp961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hebrani Paria
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Ibne-sina hospital, Buali square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
hebranip@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Pakravan Parisa
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibne-sina hospital, Buali square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
pakravanp961@mums.ac.ir
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