Fluoxetine fizzles for pediatric autism

  • Reddihough DS & al.
  • JAMA
  • 22.10.2019

  • von Emily Willingham, PhD
  • Clinical Essentials
Der Zugang zum gesamten Inhalt dieser Seite ist nur Angehörigen medizinischer Fachkreise vorbehalten. Der Zugang zum gesamten Inhalt dieser Seite ist nur Angehörigen medizinischer Fachkreise vorbehalten.

Takeaway

  • In children with autism spectrum disorders, fluoxetine yields only nonsignificant changes in obsessive-compulsive behaviors with no effects on anxiety or repetitive behaviors.
  • Baseline group differences, wide CIs muddle the trial already freighted with slow recruitment.

Why this matters

  • Editorial: results are consistent with other findings that this drug class offers little of value for repetitive behaviors, and it notes that despite overall lack of effect, frequent use of these medications has persisted.

Key results

  • Only 109 of 146 randomly allocated participants recruited over a 7-year period (from November 2010 to April 2017) completed the trial.
  • The placebo group had higher baseline scores for repetitive and “aberrant” behaviors.
  • Mean obsessive-compulsive behavior score declined from baseline to 16 weeks in both the treatment (3.72-point decrease; 95% CI, −4.85 to −2.60) and the placebo (2.53-point decrease; 95% CI, −3.86 to −1.19) groups.
    • With adjustment for baseline differences, the mean group difference was −1.17 (95% CI, −3.01 to 0.67; P=.21).
  • The trial also showed no significant changes in global behavioral measures with treatment.

Study design

  • Multicenter randomized placebo-control trial of children with autism spectrum disorders aged 7.5-18 years with a score of 6+ on Children’s Yale-Brown Obsessive Compulsive Scale–Modified for pervasive developmental disorder.
  • Primary outcome: change in obsessive-compulsive scale scores.
  • Secondary outcomes: anxiety, repetitive behaviors, global score changes.
  • Funding: National Health and Medical Research Council, Australia.

Limitations

  • Baseline difference between placebo and treatment groups.
  • High dropout rates.