N-Acetylcysteine augmentation with Rispridone in treatment of Autism in children

N-Acetylcysteine augmentation with Rispridone in treatment of Autism in children: A double blind randomized placebo controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201106103930N6

Enrollment

Registered

2011-07-08

Start date

2011-04-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Pervasive developmental disorders. Childhood autism

Interventions

Intervention 1: risperidone (0.5 to 3 mg/day)+ Placebo. Intervention 2: N-Acetylcysteine (up to 3000mg/day)+ risperidone (0.5 to 3 mg/day).

Placebo

Treatment - Drugs

risperidone (0.5 to 3 mg/day)+ Placebo

N-Acetylcysteine (up to 3000mg/day)+ risperidone (0.5 to 3 mg/day)

Eligibility

Sex/Gender

All

Age

3 Years to 16 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: DSM-IV diagnosis of autism spectrum disorders; both gender, aged 3 to 16 years. Exclusion Criteria: primary diagnosis of a psychotic disorder; active substance abuse or dependence; unstable medical condition; prior exposure to N-Acetylcysteine; evidence of active liver disease; seizure disorder; unstable hypertension or cardiac disease; unstable asthma; and kidney disease as determined by the investigator; Weight < 15 kg.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Abbrant Behavior Checklist. Timepoint: every 4 week. Method of measurement: interview.	—

Secondary

Measure	Time frame
Adverse effects. Timepoint: evey 4 week. Method of measurement: interview.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 23, 2026