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l-Carnosine As an Adjunctive Therapy to Risperidone in Children with Autistic Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial.

  • 2018-02
  • Journal of child and adolescent psychopharmacology 28(1)
    • Reihaneh Hajizadeh-Zaker
    • Alireza Ghajar
    • Bita Mesgarpour
    • Mohsen Afarideh
    • Mohammad-Reza Mohammadi
    • Shahin Akhondzadeh

Study Design

Type
Randomized Controlled Trial (RCT)
Population
Seventy drug-free children aged 4-12 years old with a diagnosis of autism spectrum disorder (ASD)
Methods
10-week, randomized, double-blind, placebo-controlled study; l-carnosine (800 mg/day in 2 divided doses) or placebo added to risperidone titrated up to 2 mg/day
Blinding
Double-blind
Duration
10 weeks
Funding
Unclear

Objectives

This study aimed at investigating the efficacy and tolerability of l-carnosine as an add-on to risperidone in the management of children with autism.

Methods

This was a 10-week, randomized, double-blind, placebo-controlled study. Seventy drug-free children aged 4-12 years old with a diagnosis of autism spectrum disorder (ASD), according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition. (DSM-5) who had an Aberrant Behavior Checklist-Community (ABC-C) scale irritability subscale score of ≥12, entered the study. The patients were randomly assigned to l-carnosine (800 mg/day in 2 divided doses) or placebo in addition to risperidone titrated up to 2 mg/day (based on body weight) for 10 weeks. The children were assessed by using ABC-C at baseline and weeks 5 and 10 post-baseline. The primary outcome measure was the mean change in the ABC-C irritability subscale score, and other subscale scores were defined as secondary outcomes.

Results

Using the general linear model repeated measures, no significant effect was observed for time × treatment interaction on the irritability subscale scores. However, significant effect was detected on the hyperactivity/noncompliance subscale [F (1.62, 64.96) = 3.53, p-value = 0.044]. No significant improvements were obtained on the lethargy/social withdrawal, stereotypic behavior, and inappropriate speech subscale scores. Significantly greater score reduction in the hyperactivity/noncompliance subscale occurred in the l-carnosine group compared with the placebo group at the end of the trial. Extrapyramidal Symptom Rating Scale Scores and its changes did not differ between the two groups. The frequency of other side effects was not significantly different between the two groups.

Conclusions

Although no significant difference was detected on the irritability subscale scores, l-carnosine add-on can improve hyperactivity/noncompliance subscales of the ABC-C rating scale in patients with ASD.

Research Insights

  • L-Carnosine→Reduced Hyperactivity

    Significant effect was detected on the hyperactivity/noncompliance subscale [F (1.62, 64.96) = 3.53, p-value = 0.044]. Significantly greater score reduction in the hyperactivity/noncompliance subscale occurred in the l-carnosine group compared with the placebo group at the end of the trial.

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    800 mg/day in 2 divided doses
  • L-Carnosine→Reduced Inappropriate Speech

    No significant improvements were obtained on the ... inappropriate speech subscale scores.

    Effect
    Neutral
    Effect size
    Small
    Dose
    800 mg/day in 2 divided doses
  • L-Carnosine→Reduced Irritability

    Using the general linear model repeated measures, no significant effect was observed for time × treatment interaction on the irritability subscale scores.

    Effect
    Neutral
    Effect size
    Small
    Dose
    800 mg/day in 2 divided doses
  • L-Carnosine→Reduced Lethargy

    No significant improvements were obtained on the lethargy/social withdrawal ... subscale scores.

    Effect
    Neutral
    Effect size
    Small
    Dose
    800 mg/day in 2 divided doses
  • L-Carnosine→Reduced Stereotypic Behavior

    No significant improvements were obtained on the ... stereotypic behavior ... subscale scores.

    Effect
    Neutral
    Effect size
    Small
    Dose
    800 mg/day in 2 divided doses

Adverse Events Reported

  • L-Carnosine→Overall tolerability

    The frequency of other side effects was not significantly different between the two groups.

    Finding
    No significant difference
    Significant
    No
  • L-Carnosine→extrapyramidal symptoms

    Extrapyramidal Symptom Rating Scale Scores and its changes did not differ between the two groups.

    Finding
    No significant difference
    Significant
    No
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