Studying the effect of L-theanine with risperidone on irritability in children with autism
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
This study will be performed on patients attending Roozbeh Hospital.
Participants/Inclusion and exclusion 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: 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
Intervention groups
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.
Main outcome variables
Severity of autism symptoms.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N170
Registration date:2026-05-13, 1405/02/23
Registration timing:prospective
Last update:2026-05-13, 1405/02/23
Update count:0
Registration date
2026-05-13, 1405/02/23
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
Expected recruitment end date
2028-05-21, 1407/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
L-theanine adjunct to risperidone for irritability of autistic children: A randomized, double-blind, placebo-controlled trial
Public title
L-theanine adjunct to risperidone in autism
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 5 years old to 11 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Medicine, Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Pour Sina St., Qods St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2026-01-27, 1404/11/07
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1405.111
Health conditions studied
1
Description of health condition studied
Autism spectrum disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Irritability
Timepoint
Beginning of the study and weeks 0 - 5 - 10
Method of measurement
By Aberrant Behavior Checklist-Community (ABC-C)
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Placebo
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Prof. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Kordi
Street address
Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 5541 2222
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2026 to 2030
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Users should cite the resource of data
From where data/document is obtainable
Prof. Shahin Akhondzadeh
What processes are involved for a request to access data/document