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Amantadine in the treatment of autism

A double - blind placebo controlled traial of Amantadine added to risperidone in patint with autistic disorder

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201106101556N25
Enrollment
50
Registered
2011-06-12
Start date
2011-07-06
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Childhood autism. Childhood autism

Interventions

Intervention 1: Capsule Amantadine 100-150 mg/day+ Tablet Risperidon 1 to 3 mg/day as intervention 10 for 10 weeks. Intervention 2: Tablet Risperidone 1-3.5 mg/day +Capsule Placebo as control for 10
Treatment - Drugs
Placebo
Capsule Amantadine 100-150 mg/day+ Tablet Risperidon 1 to 3 mg/day as intervention 10 for 10 weeks
Tablet Risperidone 1-3.5 mg/day +Capsule Placebo as control for 10 weeks

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1-DSM IV clinical diagnosis of autistic disorder, 2-children between the ages of 3 and 11 years ,3- presence of behavioral problems such as aggression, overactivity or repetitive behaviors (indication of treatment with risperidone) Exclusion Criteria:1- Presence of any active medical problem, 2-any diagnosis in Axis I and II except for mental retardation, 3-history of allergy to Amantadine,4- receiving any psychotropic medications during past six weeks prior to the trial, 5-presence of hepatic disease, 6-history of seizure

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Autism severity. Timepoint: Baseline and weeks 5,10. Method of measurement: Aberrant Behavior Checklist-Community (ABC-C) Rating Scale.;Clinical Global Impression. Timepoint: Baseline and weeks 5 and 10. Method of measurement: CGI scale.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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