Reclassifying dropouts from antipsychotic trials due to study-reported adverse events: a systematic review and individual-participant-data meta-analyses.
Eur NeuropsychopharmacolMay 15, 2026 (epub)
Clinical ResearchPsychiatry
Yuki Furukawa, Spyridon Siafis, Johannes Schneider-Thoma et al.
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In 30 seconds
This systematic review and individual-participant-data meta-analysis examined dropout reasons in antipsychotic trials for acute schizophrenia. In 17 trials involving 6823 participants, the study found no significant difference in dropouts due to adverse events (AEs) between antipsychotics and placebo (OR, 0.93). However, reclassified dropouts due to somatic AEs were more frequent with antipsychotics (OR, 1.54).
Key findings
- 1369 dropouts were due to inefficacy, 445 due to AEs, and 1173 due to other reasons.
- 223 dropouts were reclassified as psychiatric AEs, 207 as somatic AEs.
- No significant difference in study-defined dropouts due to AEs between antipsychotics and placebo (OR, 0.93).
- Dropouts reclassified as somatic AEs were more frequent with antipsychotics (OR, 1.54).
Why it matters
Understanding the reasons for dropout in antipsychotic trials is crucial for evaluating drug tolerability and efficacy. Accurate classification of AEs can inform better clinical decision-making and improve trial design.