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The effect of rosiglitazone in the treatment of autism

Rosiglitazone as an adjuvant therapy to risperidone in children with autism spectrum disorder: a randomized placebo-controlled double-blind clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090117001556N150
Enrollment
50
Registered
2023-04-24
Start date
2023-06-22
Completion date
Unknown
Last updated
2023-05-01

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: Control group: Children with autism received daily risperidone (0.5 mg per day, and 0.5 mg added up to seven days, up to a maximum dose of 3 mg per day) and placebo for 10 weeks. Inter

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 11 Years

Inclusion criteria

Inclusion criteria: Diagnosis of autism based on DSM5 and ABC-C

Exclusion criteria

Exclusion criteria: Medically active disease The presence of another psychological diagnosis in DSM 3 axis History of previous sensitivity and intolerance to rosiglitazone History of seizures and liver disorders Taking antipsychotic drugs such as Risperidone before entering the study Alanine aminotransferase (ALT) level < 2.5 at the beginning of the study

Design outcomes

Primary

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

Secondary

MeasureTime frame
The severity of hyperactivity/noncompliance. Timepoint: Baseline and weeks 5, and 10. Method of measurement: By Aberrant Behavior Checklist-Community (ABC-C).;The severity of lethargy/social withdrawal. Timepoint: Baseline and weeks 5, and 10. Method of measurement: By Aberrant Behavior Checklist-Community (ABC-C).;The severity of stereotypic behavior. Timepoint: Baseline and weeks 5, and 10. Method of measurement: By Aberrant Behavior Checklist-Community (ABC-C).;The severity of inappropriate speech. Timepoint: Baseline and weeks 5, and 10. Method of measurement: By Aberrant Behavior Checklist-Community (ABC-C).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. 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