Pregabalin for the treatment of Autism Spectrum Disorder

Investigating the Effects of Pregabalin as Adjuvant Therapy in the Treatment of Children with Autism Spectrum Disorder: A Randomized Double-blind Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090117001556N161

Enrollment

Registered

2025-03-06

Start date

2025-05-22

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Autism spectrum disorder. Autistic disorder

Interventions

Intervention 1: Intervention group: Patients receive risperidone and pregabalin for 10 weeks. Risperidone starts with an initial dose of 0.5 mg per day, and if no side effects occur, 0.5 mg is added e

Eligibility

Sex/Gender

All

Age

5 Years to 11 Years

Inclusion criteria

Inclusion criteria: Age between 5-11 years Diagnosis of autism spectrum disorder based on DSM-V Patients who have specific behavioral problems such as aggression, hyperactivity, unusual, and stereotyped behaviors

Exclusion criteria

Exclusion criteria: An active medical disease Diagnosis of another psychological disorder in DSM History of previous sensitivity and intolerance to Pregabalin Taking antipsychotic drugs such as Risperidone before entering the study

Design outcomes

Primary

Measure	Time frame
Severity of autism symptoms. 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