Pentoxifylline in the treatment of autism

A double- blind placebo controlled trial of Pentoxifylline added to Risperidone in patients with autistic disorders

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT138711161556N7

Enrollment

Registered

2009-03-13

Start date

2007-04-20

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: Tablet Pentoxifylline 400 mg/day+ Tablet Risperidon 1-3.5 mg as intervention. Intervention 2: Tablet Risperidone 1-3.5 mg/day +Tablet Placebo as control.

Treatment - Drugs

Placebo

Tablet Pentoxifylline 400 mg/day+ Tablet Risperidon 1-3.5 mg as intervention

Tablet Risperidone 1-3.5 mg/day +Tablet Placebo as control

Eligibility

Sex/Gender

All

Age

3 Years to 11 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: DSM IV clinical diagnosis of autism, children and adolescents between the ages of 3 and 11 years (inclusive), Exclusion Criteria: Presence of any active medical problem, any diagnosis in Axis I and II except for mental retatdation, history of allergy to Pentoxifylline, receiving any psychotropic medications during past two weeks prior to the trial, presence of aggressive behavior that needs Risperidone

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Severity of Autism. Timepoint: Baseline and weerks 2, 4, 6, 8, 10. Method of measurement: Aberrant Behavior Checklist-Community (ABC-C) Rating Scale.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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