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IRCT20090117001556N170 IRCT 2026-05-13 Tehran University of Medical Sciences L-theanine adjunct to risperidone in autism L-theanine adjunct to risperidone for irritability of autistic children: A randomized, double-blind, placebo-controlled trial 2026-05-22 anticipated 50 Recruiting https://irct.ir/trial/90045 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups), Blinding description: The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process. 2-3 Autism spectrum disorder. 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 will be 2-3.5 mg, with a maximum dose of 2 mg for children weighing less than 30 kg and 3.5 mg per day for children weighing 30 kg or more. Placebo will also be administered once a day for ten weeks. Intervention 2: Intervention 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 will be 2-3.5 mg, with a maximum dose of 2 mg for children weighing less than 30 kg and 3.5 mg per day for children weighing 30 kg or more. L-Theanine capsule (400 mg) (Institute of Medicinal Plants) will be prescribed once daily for ten weeks. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2026 to 2030 To whom: Academic researchers Conditions: Users should cite the resource of data Where to obtain: Prof. Shahin Akhondzadeh How to obtain: By E-mail Comments:
public Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 5 years 11 years Both 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 F84.0 Autistic disorder Placebo Treatment - Drugs 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 will be 2-3.5 mg, with a maximum dose of 2 mg for children weighing less than 30 kg and 3.5 mg per day for children weighing 30 kg or more. Placebo will also be administered once a day for ten weeks. Intervention 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 will be 2-3.5 mg, with a maximum dose of 2 mg for children weighing less than 30 kg and 3.5 mg per day for children weighing 30 kg or more. L-Theanine capsule (400 mg) (Institute of Medicinal Plants) will be prescribed once daily for ten weeks. Irritability. Timepoint: Beginning of the study and weeks 0 - 5 - 10. Method of measurement: By Aberrant Behavior Checklist-Community (ABC-C). Tehran University of Medical Sciences Approved 2026-01-27 Ethics Committee of School of Medicine, Tehran University of Medical Sciences Tehran University of Medical Sciences, Pour Sina St., Qods St., Enghelab St. Tehran Tehran Iran (Islamic Republic of)