Breakthrough Tracker record
One anomalous trial materially distorted meta-analytic support for paediatric fluoxetine
Lyus and collaborators trace conflicting network meta-analyses to a 40-participant active-comparator trial with an implausibly large, unusually orderly effect and missing methodological details. Reanalysis without it removed the outsized fluoxetine advantage.
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- Stable ID
medicine-fluoxetine-trial-meta-analysis-reappraisal-2026- Revision
medicine-fluoxetine-trial-meta-analysis-reappraisal-2026.v1- Field
- Medicine · Psychiatry, evidence synthesis and research integrity
- Evidence
- Tier 1 · Peer reviewed: Yes
- Record state
- Current · Peer-reviewed evidence reappraisal
- Last checked
AI role
No substantive AI role was disclosed in the inspected article, preprint or independent reporting.
Record details
- Problem or result
- Integrity and sensitivity of evidence for fluoxetine in paediatric depression
- Authors
- Richard Lyus, Florian Naudet, Gert van Valkenhoef and Martin Plöderl
- Institutions
- Affiliations in the version of record span UK child and adolescent psychiatry, University of Rennes, University of Groningen and Paracelsus Medical Private University
- Result date
- Peer-reviewed online article and independent specialist reporting in October 2026
Why it matters
The analysis shows how one small, apparently unreliable trial can materially change a high-level evidence network used in paediatric treatment discussions, separating data-integrity risk from an ordinary statistical disagreement.
Limits
This is not a retraction, regulator decision, proof that fluoxetine is ineffective or advice to stop treatment. The questioned trial remained published at the cutoff, earlier reviews had already rated confidence very low, and total benefit–risk decisions require the full evidence base and individualized clinical care.
Sources
- Primary: Cochrane Evidence Synthesis and Methods, fluoxetine evidence reappraisal
- Preprint: Public preprint and analysis trail
- Independent context: Nature report on the anomalous trial and meta-analyses
Correction and revision history
- 2026-10-05 — Added after primary-source, scope, status, AI-role and limitation review.
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