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Selective outcome reporting and non-reporting in trials of psychedelic drugs for mental disorders

Summary

Researchers examined whether studies of three promising psychedelic drugs (esketamine, psilocybin, and MDMA) for treating mental health conditions were reporting their results fairly and completely. They found that nearly 29% of completed trials had no published results, and some studies changed which outcomes they reported on between registration and publication. This selective reporting could make these drugs appear more effective than they actually are.

Background

Selective reporting of outcome data (SOR) refers to trialists selecting results for publication based on a subset of initially measured outcomes. This practice has not been thoroughly examined for profitable treatments in critical regulatory periods. The study focuses on three prominent psychedelic drugs: esketamine, psilocybin, and MDMA.

Objective

To examine the prevalence and types of selective outcome reporting (SOR) in randomized trials of esketamine, psilocybin, and MDMA for mental disorders. The study aims to assess how often trial results are selectively reported or not reported at all during critical regulatory approval periods.

Results

Of 98 randomized trials identified, 56 had completed or unknown status as of July 2024. Sixteen trials (28.5%) had no publication or posted results. Twenty-nine trials (51%) had peer-reviewed publications, with primary outcome changes in 2 trials (7%) and timepoint assessment changes in 7 trials (24%).

Conclusion

Selective reporting and non-reporting are present in trials of prominent psychedelic drugs, though difficult to assess due to limited clinical trial registry information. Full access to all time-stamped protocol versions and statistical analysis plans would be necessary to fully gauge the extent and types of selective outcome reporting.
  • Published in:European Psychiatry,
  • Study Type:Systematic Review / Registry Analysis,
  • Source: 10.1192/j.eurpsy.2025.393, PMC12436740
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