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Efficacy of pregnenolon in treatment of irritability inteeanagers with autism

Efficacy of pregnenolon in treatment of irritability in teeanagers with autism;A double blind and placebo controlled triall

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090117001556N112
Enrollment
40
Registered
2018-07-25
Start date
2018-08-05
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistic disorder. Autistic disorder

Interventions

Intervention 1: Intervention group: Cap. ?( 100 BID) plus Risperidone ( 2.5 to 3.5 mg per day) for 10 weeks. Intervention 2: Control group: tablet placebo plus Risperidone( 2.5 to 3.5 mg per day) for

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
11 Years to 17 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Severity of autism. Timepoint: Baseline and weeks 5, and 10. Method of measurement: By Aberrant Behavior Checklist-Community( ABC-C).

Countries

Iran (Islamic Republic of)

Contacts

Public Contact????? ?????????

Tehran University of Medical Sciences

s.akhond@sina.tums.ac.ir+98 21 5541 2222

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026