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Minocycline as Adjunctive Treatment to Risperidone in Children with Autistic Disorder: A Randomized, Double-Blind
Ali Ghaleiha1, Rosa Alikhani2, Mohammad-Reza Kazemi3
11 Behavioral Disorders and Substance Abuse Research Center, Hamadan University of Medical Sciences , Hamadan, Iran .
Insights
Minocycline, when added to risperidone, improved irritability and hyperactivity in children with autism. This treatment was safe and effective, with no significant difference in adverse events compared to placebo.
Area of Science:
- Neuroscience
- Pharmacology
- Child Psychiatry
Background:
- Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition.
- Behavioral challenges, including irritability and hyperactivity, are common in children with ASD.
- Risperidone is an antipsychotic medication often used to manage severe behavioral problems in ASD.
Purpose of the Study:
- To investigate the efficacy and safety of minocycline as an adjunctive treatment to risperidone in children with autistic disorder.
- To evaluate the impact of minocycline on irritability, hyperactivity, and other behavioral symptoms in this population.
Main Methods:
- A randomized controlled trial was conducted with 46 children diagnosed with autistic disorder.
- Participants received either minocycline (50 mg twice daily) or placebo, in addition to risperidone (up to 2 mg/day) for 10 weeks.
- The Aberrant Behavior Checklist-Community (ABC-C) was used to assess behavioral changes at baseline, week 5, and week 10.
Main Results:
- A significant time × treatment interaction was observed for irritability and hyperactivity/noncompliance, indicating minocycline's positive effect.
- By week 10, 91.3% of patients in the minocycline group achieved at least partial response, compared to 65.5% in the placebo group (p=0.03).
- No significant differences in the frequency of adverse events were found between the minocycline and placebo groups.
Conclusions:
- Minocycline appears to be a safe and effective adjuvant therapy for managing behavioral symptoms in children with autistic disorder.
- Further research with larger sample sizes and longer follow-up periods is recommended to confirm these findings and explore the mechanism of action.
Objective:
This is an investigation of minocycline efficacy and safety as an adjuvant to risperidone in management of children with autism.
Methods:
Forty-six children with diagnosis of autistic disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria and a score of ≥12 on the Aberrant Behavior Checklist-Community (ABC-C) irritability subscale, who were already drug-free for at least 6 months participated in a randomized controlled trial and underwent 10 weeks of treatment with either minocycline (50 mg twice per day) or placebo in addition to risperidone titrated up to 2 mg/day (based on bodyweight). Patients were evaluated using ABC-C at baseline and at weeks 5 and 10.
Results:
General linear model repeated measures showed significant effect for time × treatment interaction on the irritability [F(2, 88) = 3.94, p = 0.02] and hyperactivity/noncompliance [F(1.50, 66.05) = 7.92, p = 0.002], but not for lethargy/social withdrawal [F(1.61, 71.02) = 0.98, p = 0.36], stereotypic behavior [F(1.34, 58.80) = 1.55, p = 0.22], and inappropriate speech subscale scores [F(1.52, 66.88) = 1.15, p = 0.31]. By week 10, 21 (91.3%) patients in the minocycline group and 15 (65.5%) patients in the placebo group achieved at least partial response (p = 0.03). Frequencies of adverse events were not significantly different between groups.
Conclusions:
Minocycline seems to be a safe and effective adjuvant in management of patients with autistic disorder. Future studies with larger sample sizes, longer follow-ups, and inflammatory cytokine measurements are warranted to confirm these findings and provide insight into minocycline mechanism of action in autistic disorder.
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