Momtazmanesh · 2020 · Psychiatry and clinical neurosciences
Risperidone combination treatment and irritability/hyperactivity
Did adding sulforaphane to risperidone change irritability ratings?
Human · randomized controlled trial with medication combination
Key findings
Difference in the primary irritability outcome
At 10 weeks, irritability scores fell by 10.27 points in the SFN plus risperidone group and 7.10 points in the placebo plus risperidone group, a 3.17-point greater reduction with SFN (p=0.001).
Difference in hyperactivity/noncompliance
The reduction in hyperactivity/noncompliance was 7.70 versus 4.23 points, a 3.47-point greater reduction with SFN combination treatment (p=0.015).
Other behavioral domains and adverse events
There were no significant differences in lethargy/social interaction, stereotypic behavior, inappropriate speech, or adverse-event frequency.
Detailed results
The study asked what changed when sulforaphane was added to the same medication.
Sixty children aged 4–12 years participated for 10 weeks, and both groups used risperidone. The comparison was risperidone plus placebo versus risperidone plus sulforaphane. The primary outcome was caregiver-rated ABC-C irritability; hyperactivity/noncompliance and other subscales were secondary outcomes.
| Assessment | Sulforaphane + medication | Placebo + medication | Between-group comparison |
|---|---|---|---|
| Irritability · primary outcome | 10.27 points | 7.10 points | p=0.001 |
| Hyperactivity/noncompliance | 7.70 points | 4.23 points | p=0.015 |
Thirty participants per group. The additional reductions were 3.17 points for irritability (95% CI 1.27–5.06) and 3.47 points for hyperactivity/noncompliance (0.68–6.25).
Score change from baseline to week 10
Mean irritability scores changed from 22.50 to 12.23 in the sulforaphane combination group and from 21.30 to 14.20 in the placebo combination group. Baseline scores differed, and the p value comparing final scores alone was 0.123. The primary result of p=0.001 compares reductions over ten weeks.
Behavioral domains and trial conditions with observed effects
There were no significant between-group differences in lethargy/social withdrawal, stereotypic behavior, or inappropriate speech. Changes in irritability and hyperactivity at week five were also not significant. Significant differences in these outcomes were observed under the ten-week combination condition.
Study design
Children not previously taking medication were divided between risperidone plus SFN and risperidone plus placebo. Caregiver behavior ratings were compared at baseline, week five, and week ten.
- Participants
- Sixty children with ASD · ages 4–12
Both groups used risperidone - Intake and observation
- SFN 50–100 µmol/day or placebo
With risperidone · 10 weeks - Measures
- ABC-C irritability (primary), hyperactivity/noncompliance, and other subscales
Study context
A ten-week adjunctive therapy trial in which both groups used medication. The study assessed the effect of adding sulforaphane to risperidone.
Original paper and sources
Sulforaphane as an adjunctive treatment for irritability in children with autism spectrum disorder: A randomized, double-blind, placebo-controlled clinical trial.
- Journal
- Psychiatry and clinical neurosciences · 2020 · 74(7): 398-405
- First published
- 2020-04-29