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pioglitazone in the treatment of autism

pioglitazone added to risperidone in the treatment of Autism: A double blind and placebo controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201202281556N37
Enrollment
40
Registered
2012-03-01
Start date
2012-03-15
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 Pioglitazone 30 mg/day+ Tablet Risperidon 1-2 mg/day as intervention for 10 weeks. Intervention 2: Tablet Risperidone 1-2 mg/day +Capsule Placebo as control for 10 weeks.
Treatment - Drugs
Placebo
Tablet Pioglitazone 30 mg/day+ Tablet Risperidon 1-2 mg/day as intervention 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 two weeks prior to the trial, 5-presence of hepatic disease, 6-history of seizure

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactProf. Shahin Akhondzadeh

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