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Baclofen as an adjuvant therapy for autism: a randomized, double-blind, placebo-controlled trial.

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Title: Baclofen as an adjuvant therapy for autism: a randomized, double-blind, placebo-controlled trial.
Authors: Mahdavinasab, Seyedeh-Mahsa, Saghazadeh, Amene, Motamed-Gorji, Nogol, Vaseghi, Salar, Mohammadi, Mohammad-Reza, Alichani, Rosa, Akhondzadeh, Shahin
Source: European Child & Adolescent Psychiatry. Dec2019, Vol. 28 Issue 12, p1619-1628. 10p. 1 Diagram, 5 Charts.
Subjects: Risperidone, Autism, Combination drug therapy, Confidence intervals, Drug interactions, GABA agonists, Statistical sampling, Randomized controlled trials, Treatment effectiveness, Blind experiment, Baclofen, Descriptive statistics, Symptoms, Children
Abstract: Increasing evidence suggests that the function of the GABAergic system is abnormally low in autism spectrum disorder (ASD). Baclofen, which functions as a selective agonist for GABAB receptors, does appear promising for the treatment of ASD. We conducted a 10-week randomized-controlled study aimed at evaluating the potential of baclofen as an adjuvant therapy to enhance the effect of risperidone in children with ASD. Sixty-four children (3–12 years) with moderate-to-severe irritability symptoms of ASD were included. We used the Aberrant Behavior Checklist-Community Edition (ABC-C) for the outcome measures on each of the follow-up visits (weeks 0, 5, and 10). Analysis of the combined data revealed significant improvement for all the ABC subscales (irritability: F = 51.644, df = 1.66, p < 0.001, lethargy: F = 39.734, df = 1.38, p < 0.001, stereotypic behavior: F = 25.495, df = 1.56, p < 0.001, hyperactivity: F = 54.135, df = 1.35, p < 0.001, and inappropriate speech: F = 19.277, df = 1.47, p = 0.004). Combined treatment with baclofen and risperidone exerted a greater effect on improvement of hyperactivity symptoms at both midpoint [Cohen's d, 95% confidence interval (CI) = − 3.14, − 5.56 to − 0.72] and endpoint (d, 95% CI = − 4.45, − 8.74 to − 0.16) when compared with treatment with placebo plus risperidone. The two treatments achieved comparable results for other outcome measures. Our data support safety and efficacy of baclofen as an adjuvant to risperidone for improvement of hyperactivity symptoms in children with ASD. [ABSTRACT FROM AUTHOR]
Copyright of European Child & Adolescent Psychiatry is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Baclofen as an adjuvant therapy for autism: a randomized, double-blind, placebo-controlled trial.
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  Data: Increasing evidence suggests that the function of the GABAergic system is abnormally low in autism spectrum disorder (ASD). Baclofen, which functions as a selective agonist for GABAB receptors, does appear promising for the treatment of ASD. We conducted a 10-week randomized-controlled study aimed at evaluating the potential of baclofen as an adjuvant therapy to enhance the effect of risperidone in children with ASD. Sixty-four children (3–12 years) with moderate-to-severe irritability symptoms of ASD were included. We used the Aberrant Behavior Checklist-Community Edition (ABC-C) for the outcome measures on each of the follow-up visits (weeks 0, 5, and 10). Analysis of the combined data revealed significant improvement for all the ABC subscales (irritability: F = 51.644, df = 1.66, p &lt; 0.001, lethargy: F = 39.734, df = 1.38, p &lt; 0.001, stereotypic behavior: F = 25.495, df = 1.56, p &lt; 0.001, hyperactivity: F = 54.135, df = 1.35, p &lt; 0.001, and inappropriate speech: F = 19.277, df = 1.47, p = 0.004). Combined treatment with baclofen and risperidone exerted a greater effect on improvement of hyperactivity symptoms at both midpoint [Cohen&#39;s d, 95% confidence interval (CI) = − 3.14, − 5.56 to − 0.72] and endpoint (d, 95% CI = − 4.45, − 8.74 to − 0.16) when compared with treatment with placebo plus risperidone. The two treatments achieved comparable results for other outcome measures. Our data support safety and efficacy of baclofen as an adjuvant to risperidone for improvement of hyperactivity symptoms in children with ASD. [ABSTRACT FROM AUTHOR]
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  Data: &lt;i&gt;Copyright of European Child &amp; Adolescent Psychiatry is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder&#39;s express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
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    Identifiers:
      – Type: doi
        Value: 10.1007/s00787-019-01333-5
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      – Code: eng
        Text: English
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      Pagination:
        PageCount: 10
        StartPage: 1619
    Subjects:
      – SubjectFull: Risperidone
        Type: general
      – SubjectFull: Autism
        Type: general
      – SubjectFull: Combination drug therapy
        Type: general
      – SubjectFull: Confidence intervals
        Type: general
      – SubjectFull: Drug interactions
        Type: general
      – SubjectFull: GABA agonists
        Type: general
      – SubjectFull: Statistical sampling
        Type: general
      – SubjectFull: Randomized controlled trials
        Type: general
      – SubjectFull: Treatment effectiveness
        Type: general
      – SubjectFull: Blind experiment
        Type: general
      – SubjectFull: Baclofen
        Type: general
      – SubjectFull: Descriptive statistics
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      – SubjectFull: Symptoms
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      – SubjectFull: Children
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      – TitleFull: Baclofen as an adjuvant therapy for autism: a randomized, double-blind, placebo-controlled trial.
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              M: 12
              Text: Dec2019
              Type: published
              Y: 2019
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