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Efficacy of pregnenolon in treatment of irritability inteeanagers with autism

Phase 3
Recruiting
Conditions
F84.0
Autistic disorder.
Autistic disorder
Registration Number
IRCT20090117001556N112
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria

DSM-5 clinical diagnosis of autistic disorder
Teenagers between the ages of 11and 17 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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of autism. Timepoint: Baseline and weeks 5, and 10. Method of measurement: By Aberrant Behavior Checklist-Community( ABC-C).
Secondary Outcome Measures
NameTimeMethod
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