Protocol summary
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Study aim
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The objective of this study is to assess the efficacy of folinic acid in the treatment of autism
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Design
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Randomized double blind and placebo-controlled clinical trial
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Settings and conduct
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The study will be conducted among children with autistic disorder attending Roozbeh Hospital
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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severity of autism
General information
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Reason for update
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change age
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Acronym
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IRCT registration information
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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
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Registration date
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2018-11-15, 1397/08/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-22, 1397/09/01
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Expected recruitment end date
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2021-03-21, 1400/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Folinic acid in the treatment of autism spectrum disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 4 years old to 12 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random permuted block
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The participants, clinicians and outcome raters will be blind regarding grouping
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-23, 1397/08/01
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Ethics committee reference number
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IR.TUMS.VCR.REC.1397.503
Health conditions studied
1
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Description of health condition studied
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Autistic disorder
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ICD-10 code
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F84.0
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ICD-10 code description
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Autistic disorder
Primary outcomes
1
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Description
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Severity of autism
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Timepoint
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Baseline and weeks 5, and 10
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Method of measurement
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By Aberrant Behavior Checklist-Community( ABC-C) and Childhood Autism Rating scale( CARS)
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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Control group: Tablet placebo plus Risperidone( 1 to 3.5 mg per day) for 12 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The data will be distributed through final report
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When the data will become available and for how long
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5 years from 2021 to 2026
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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by citing the resourse
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From where data/document is obtainable
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Professor Shahin Akhondzadeh
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What processes are involved for a request to access data/document
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by E mail
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Comments
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