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Efficacy of N-Acetyl cysteine in patients with autism spectrum disorder

Evaluating the efficacy of adding N-Acetyl cysteine to risperidone treatment regimen in patients with autism spectrum disorder

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190714044199N1
Enrollment
66
Registered
2019-11-10
Start date
2019-08-23
Completion date
Unknown
Last updated
2019-12-17

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

Conditions

Autism spectrum disorder. Childhood autism

Interventions

Intervention 1: Case group: 33 patients treated with risperidone tablets with a maximum dose of 1.5 mg daily and n-acetylcysteine tablets 600 mg daily. Intervention 2: Control group: 33 patients treat

Sponsors

Medical Science University of Mashhad
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: Autism spectrum disorder (ASD) patients aging between 3 to 12 Having parental informed consent IQ score greater than 50 based on Wildland Test Receiving risperidone therapy for at least one month Lack of clear organic disease (based on family history and medical records) Clear organic causes include visual and hearing impairment, seizures, trauma cycles, chronic or acute medical disorder, and brain dysfunction. Psychiatric disorders including Toure's syndrome, Fragile X syndrome, schizophrenia, Attension deficit hyperactivity disorder (ADHD) based on structured psychiatric interview conducted by pediatric psychiatrist

Exclusion criteria

Exclusion criteria: If the parents do not cooperate for any reason after entering the study 2- 3- Use of any psychotropic drugs other than risperidone Any unbearable or life-threatening drug side effect or any other illness that requires medication which may interfere with results of this study.

Design outcomes

Primary

MeasureTime frame
Severity of ASD was evaluated by CARS questionnaire. Timepoint: Baseline, 5 and 10 weeks after baseline. Method of measurement: CARS questionnaires.;Severity, drug response and drug adverse effects was evaluated by CGI questionnaire. Timepoint: Baseline, 5 and 10 weeks after baseline. Method of measurement: CGI questionnaires.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPakravan Parisa

Mashhad University of Medical Sciences

pakravanp961@mums.ac.ir+98 51 3711 2701

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026