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L-theanine adjunct to risperidone in autism

L-theanine adjunct to risperidone for irritability of autistic children: A randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090117001556N170
Enrollment
50
Registered
2026-05-13
Start date
2026-05-22
Completion date
Unknown
Last updated
2026-06-01

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: Control group: Risperidone (Risperdal
Janssen Pharmaceuticals, Beerse, Belgium) started at a dose of 0.5 mg and increased by 0.5 mg per week if there are no side effects (for the first three weeks). The therapeutic range for risperidone w

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

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: Previous prominent psychiatric disorders (e.g., depression) Comorbidities History of allergy or intolerance to risperidone or L-theanine History of seizure or liver dysfunction History of treatment with antipsychotic medications in the past six months

Design outcomes

Primary

MeasureTime frame
Irritability. Timepoint: Beginning of the study and weeks 0 - 5 - 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: Jun 11, 2026