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Folinic acid add on therapy to risperidone in symptoms of children with autism: a randomized double-blind placebo-controlled clinical trial

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History
# Registration date Revision Id
2 2020-03-22, 1399/01/03 126272
1 2018-11-15, 1397/08/24 67122
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  • Protocol summary

    Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder children between the ages of 3 and 12 years; presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone). Exlusion criteria: presence of any active medical problem other psychiatric diagnosis except for mild to moderate intellectual disability; receiving any antipsychotic medications during past month prior to the trial; severe hepatic disease; history of allergy to risperidone and intolerance of it; history of seizure requiring change of antiepileptic dose during the last month; seizure during the last 6 months.
    Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder children between the ages of 4 and 12 years; presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone). Exlusion criteria: presence of any active medical problem other psychiatric diagnosis except for mild to moderate intellectual disability; receiving any antipsychotic medications during past month prior to the trial; severe hepatic disease; history of allergy to risperidone and intolerance of it; history of seizure requiring change of antiepileptic dose during the last month; seizure during the last 6 months.
    ملاکهای ورود: داشتن معیارهای تشخیص DSM-5 برای اختلال اوتیستیک سن 12-3 سال وجود مشکلات رفتاری خاص مانند پرخاشگری، بیقراری، رفتارهای تکراری که اندیکاسیون درمان با ریسپریدون وجود داشته باشد، ملاکهای خروج: هر گونه بیماری مدیکال فعال وجود تشخیص روانپزشکی دیگری بغیر از عقب ماندگی ذهنی خفیف تا متوسط مصرف هر گونه داروی آنتی سایکوتیک حداقل یک ماه قبل از پژوهش اختلال کبدی شدید سابقه حساسیت قبلی به ریسپریدون وعدم تحمل دارو سابقه تشنجی که در یکماه اخیر دوز دارو جهت کنترل تشنج تغییر کرده باشد در 6ماه اخیر تشنج داشته باشد
    ملاکهای ورود: داشتن معیارهای تشخیص DSM-5 برای اختلال اوتیستیک سن 12-4 سال وجود مشکلات رفتاری خاص مانند پرخاشگری، بیقراری، رفتارهای تکراری که اندیکاسیون درمان با ریسپریدون وجود داشته باشد، ملاکهای خروج: هر گونه بیماری مدیکال فعال وجود تشخیص روانپزشکی دیگری بغیر از عقب ماندگی ذهنی خفیف تا متوسط مصرف هر گونه داروی آنتی سایکوتیک حداقل یک ماه قبل از پژوهش اختلال کبدی شدید سابقه حساسیت قبلی به ریسپریدون وعدم تحمل دارو سابقه تشنجی که در یکماه اخیر دوز دارو جهت کنترل تشنج تغییر کرده باشد در 6ماه اخیر تشنج داشته باشد
    The participants will be randomly allocated into two groups. Intervention group(25 persons) will receive folinic acid(2 mg/kg up to 50 mg per day) and risperidone ( 1 to 3.5 mg per day) and control group( 25 persons) will receive risperidone( 1 to 3.5 mg per day) for 12 weeks.
    The participants will be randomly allocated into two groups. Intervention group(25 persons) will receive folinic acid(2 mg/kg up to 50 mg per day) and risperidone ( 1 to 3.5 mg per day) and control group( 25 persons) will receive risperidone( 1 to 3.5 mg per day) for 10 weeks.
    شرکت کنندگان به صورت تصادفی به دو گروه تقسیم می شوند. گروه مداخله( 25 نفر) برای 12 هفته اسید فولینیک(2میلیگرم به ازای هرکیلوگرم وزن بدن حداکثر 50 میلیگرم در روز) و ریسپریدون (1 تا سه و نیم میلیگرم در روز ) برای 12 هفته دریافت خواهند کرد. گروه کنترل (25 نفر) برای دوازده هفته ریسپریدون (1 تا سه و نیم میلیگرم در روز) و دارونما دریافت خواهند کرد.
    شرکت کنندگان به صورت تصادفی به دو گروه تقسیم می شوند. گروه مداخله( 25 نفر) برای 12 هفته اسید فولینیک(2میلیگرم به ازای هرکیلوگرم وزن بدن حداکثر 50 میلیگرم در روز) و ریسپریدون (1 تا سه و نیم میلیگرم در روز ) برای 10 هفته دریافت خواهند کرد. گروه کنترل (25 نفر) برای دوازده هفته ریسپریدون (1 تا سه و نیم میلیگرم در روز) و دارونما دریافت خواهند کرد.

  • General information

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    تغییر سن حداقل
    DSM-5 clinical diagnosis of autistic disorder
    Children between the ages of 3 and 12 years old
    Presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone)
    DSM-5 clinical diagnosis of autistic disorder
    Children between the ages of 4 and 12 years old
    Presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone)
    داشتن معیارهای تشخیص DSM-5 برای اختلال اوتیستیک
    سن 12-3 سال
    وجود مشکلات رفتاری خاص مانند پرخاشگری، بیقراری، رفتارهای تکراری که اندیکاسیون درمان با ریسپریدون وجود داشته باشد
    داشتن معیارهای تشخیص DSM-5 برای اختلال اوتیستیک
    سن 12-4 سال
    وجود مشکلات رفتاری خاص مانند پرخاشگری، بیقراری، رفتارهای تکراری که اندیکاسیون درمان با ریسپریدون وجود داشته باشد

  • Primary outcomes

    #1
    Baseline and weeks 4, 8 and 12
    Baseline and weeks 5, and 10
    ابتدای مطالعه و هفته 4 و 8 و 12
    ابتدای مطالعه و هفته 5 و 10

Protocol summary

Study aim
The objective of this study is to assess the efficacy of folinic acid in the treatment of autism
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
The study will be conducted among children with autistic disorder attending Roozbeh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: DSM-5 clinical diagnosis of autistic disorder children between the ages of 4 and 12 years; presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone). Exlusion criteria: presence of any active medical problem other psychiatric diagnosis except for mild to moderate intellectual disability; receiving any antipsychotic medications during past month prior to the trial; severe hepatic disease; history of allergy to risperidone and intolerance of it; history of seizure requiring change of antiepileptic dose during the last month; seizure during the last 6 months.
Intervention groups
The participants will be randomly allocated into two groups. Intervention group(25 persons) will receive folinic acid(2 mg/kg up to 50 mg per day) and risperidone ( 1 to 3.5 mg per day) and control group( 25 persons) will receive risperidone( 1 to 3.5 mg per day) for 10 weeks.
Main outcome variables
severity of autism

General information

Reason for update
change age
Acronym
IRCT registration information
IRCT registration number: IRCT20090117001556N114
Registration date: 2018-11-15, 1397/08/24
Registration timing: prospective

Last update: 2020-03-22, 1399/01/03
Update count: 1
Registration date
2018-11-15, 1397/08/24
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Folinic acid add on therapy to risperidone in symptoms of children with autism: a randomized double-blind placebo-controlled clinical trial
Public title
Folinic acid in the treatment of autism spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
DSM-5 clinical diagnosis of autistic disorder Children between the ages of 4 and 12 years old Presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone)
Exclusion criteria:
Presence of any active medical problem Other psychiatric diagnosis except for mild to moderate Intellectual disability Receiving any antipsychotic medications during past monthprior to the trial Severe hepatic disease History of allergy to risperidone and intolerance of it History of seizure requiring change of antiepileptic dose during the last month Seizure during the last 6 months
Age
From 4 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Random permuted block
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome raters will be blind regarding grouping
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
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-10-23, 1397/08/01
Ethics committee reference number
IR.TUMS.VCR.REC.1397.503

Health conditions studied

1

Description of health condition studied
Autistic disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder

Primary outcomes

1

Description
Severity of autism
Timepoint
Baseline and weeks 5, and 10
Method of measurement
By Aberrant Behavior Checklist-Community( ABC-C) and Childhood Autism Rating scale( CARS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Tab letfolinic acid( 2mg/kg per day up to 50 mg/day) plus Risperidone ( 1 to 3.5 mg per day) for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Tablet placebo plus Risperidone( 1 to 3.5 mg per day) for 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. M.R. Mohammadi
Street address
Roozbeh Hospital, South Kargar Street,
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 2756
Email
mohammadimr@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@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
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2021 to 2026
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
by citing the resourse
From where data/document is obtainable
Professor Shahin Akhondzadeh
What processes are involved for a request to access data/document
by E mail
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