Placebo response and its determinants in children with ADHD across multiple observers and settings: A randomized

Weam Fageera1,2, Alexandru Traicu3, Sarojini M Sengupta1,3

  • 1Douglas Mental Health University Institute, Montreal, Quebec, Canada.

Insights

Placebo response (PR) in children with attention deficit hyperactivity disorder (ADHD) is significant, with parents reporting larger effects than teachers. Psychosocial factors influence this response, impacting clinical trial design.

Area of Science:

  • Psychiatry
  • Pediatrics
  • Clinical Psychology

Background:

  • Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children.
  • Placebo response (PR) is a significant factor in clinical trials for ADHD medications.
  • Understanding PR determinants is crucial for accurate treatment evaluation.

Purpose of the Study:

  • To quantify placebo response (PR) in children with ADHD.
  • To compare PR as assessed by parents versus teachers.
  • To identify determinants of PR in ADHD clinical trials.

Main Methods:

  • Recruited 540 children (ages 6-12) with ADHD for a randomized, double-blind, placebo-controlled crossover trial.
  • Utilized Conners' Global Index (CGI) for parent (CGI-P) and teacher (CGI-T) behavioral assessments.
  • Calculated PR as the difference in CGI scores from baseline to placebo week.

Main Results:

  • Significant PR observed by both parents and teachers (p < 0.001).
  • Parents reported a greater magnitude of PR (10.57 points) than teachers (3.93 points).
  • Determinants of PR differed: parental factors (income, marital status, education, maternal smoking, prior psychostimulant exposure) and teacher factors (ethnicity, prior psychostimulant exposure).

Conclusions:

  • PR in pediatric ADHD is significant and varies by assessment setting and evaluator.
  • Psychosocial factors significantly modulate PR in children with ADHD.
  • Findings inform the design and interpretation of ADHD clinical trials and clinical practice.

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