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l-Carnosine as Adjunctive Therapy in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

  • 2018-06
  • Journal of child and adolescent psychopharmacology 28(5)
    • Alireza Ghajar
    • Farinaz Aghajan-Nashtaei
    • Mohsen Afarideh
    • Mohammad-Reza Mohammadi
    • Shahin Akhondzadeh

Study Design

Type
Randomized Controlled Trial (RCT)
Population
56 drug-free children and adolescents aged 6-17 years old with a diagnosis of ADHD
Methods
Randomized, double-blind placebo-controlled study; l-carnosine (800 mg/d in two divided doses) or placebo plus methylphenidate (0.5-1.5 mg/kg/d) for 8 weeks
Blinding
Double-blind
Duration
8 weeks
Funding
Unclear

Objectives

This study aimed to investigate the efficacy and tolerability of l-carnosine as an add-on to methylphenidate in management of children with attention-deficit/hyperactivity disorder (ADHD).

Methods

This was an 8-week, randomized, double-blind placebo-controlled study. Fifty-six drug-free children and adolescents aged 6-17 years old with a diagnosis of ADHD entered the study. The patients were randomly assigned to l-carnosine (800 mg/d in two divided doses) or placebo plus methylphenidate (0.5-1.5 mg/kg/d) for 8 weeks. Children were assessed using the Teacher and Parent ADHD Rating Scale-IV (ADHD-RS-IV) at baseline and at weeks 4 and 8 postbaseline.

Results

Fifty patients completed the study, and all had two postbaseline measurements. Using the general linear model repeated measures, significant effect was observed for time × treatment interaction on total and inattention subscales of the Parent ADHD-RS (Greenhouse-Geisser corrected: F = 3.783, df = 1.444, p = 0.041 and F = 4.032, df = 1.600, p = 0.030). Improvements in the Teacher ADHD-RS were not significantly different between the two groups in total (Greenhouse-Geisser corrected: F = 0.200, df = 1.218, p = 0.705), as well as inattention and hyperactivity subscale scores (p = 0.956 and 0.281, respectively). The frequency of side effects was not significantly different between the two treatment arms.

Conclusions

l-carnosine, as a supplementary medication, might be beneficial in treatment of children with ADHD. However, further investigations and different doses of l-carnosine are required to replicate these findings in children with ADHD.

Research Insights

  • L-Carnosine→Improved Attention Span

    Improvements in the Teacher ADHD-RS were not significantly different between the two groups in total, as well as inattention and hyperactivity subscale scores (p = 0.956 and 0.281, respectively)

    Effect
    Neutral
    Effect size
    Small
    Dose
    800 mg/d in two divided doses
  • L-Carnosine→Reduced ADHD Symptom

    Improvements in the Teacher ADHD-RS were not significantly different between the two groups in total (Greenhouse-Geisser corrected: F = 0.200, df = 1.218, p = 0.705)

    Effect
    Neutral
    Effect size
    Small
    Dose
    800 mg/d in two divided doses
  • L-Carnosine→Reduced ADHD Symptoms

    Using the general linear model repeated measures, significant effect was observed for time × treatment interaction on total and inattention subscales of the Parent ADHD-RS (Greenhouse-Geisser corrected: F = 3.783, df = 1.444, p = 0.041 and F = 4.032, df = 1.600, p = 0.030).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    800 mg/d in two divided doses
  • L-Carnosine→Reduced Hyperactivity

    Improvements in the Teacher ADHD-RS were not significantly different between the two groups in total (Greenhouse-Geisser corrected: F = 0.200, df = 1.218, p = 0.705), as well as inattention and hyperactivity subscale scores (p = 0.956 and 0.281, respectively).

    Effect
    Neutral
    Effect size
    Small
    Dose
    800 mg/d in two divided doses
  • L-Carnosine→Reduced Hyperactivity Symptoms

    Improvements in the Teacher ADHD-RS were not significantly different between the two groups in total, as well as inattention and hyperactivity subscale scores (p = 0.956 and 0.281, respectively)

    Effect
    Neutral
    Effect size
    Small
    Dose
    800 mg/d in two divided doses
  • L-Carnosine→Reduced Inattention Symptoms

    significant effect was observed for time × treatment interaction on total and inattention subscales of the Parent ADHD-RS (Greenhouse-Geisser corrected: F = 3.783, df = 1.444, p = 0.041 and F = 4.032, df = 1.600, p = 0.030).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    800 mg/d in two divided doses

Adverse Events Reported

  • L-Carnosine→Overall tolerability

    The frequency of side effects was not significantly different between the two treatment arms.

    Finding
    No significant difference
    Significant
    No
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