Well-being as a primary endpoint in clinical trials: a call for consensus.

Elliot Marseille, Hannes Kettner, Tyrone J Sgambati, James G Kahn, Stefano Bertozzi, Will Lucas, Robin Carhart Harris, Dacher Keltner, Charles Raison

Abstract readReview

PubMed Full text at PMC Publisher

In one paragraph

Review in Npj mental health research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact

1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Elliot MarseilleCollaboration for the Economics of Psychedelics, University of California Berkeley, Berkeley, CA, USA. emarseille1@berkeley.edu.

Hannes KettnerImperial College, London, UK.

Tyrone J SgambatiUC Berkeley, Center for the Science of Psychedelics, University of California, Berkeley, Berkeley, USA.

James G KahnGlobal Mental Health, University of California San Francisco, San Francisco, CA, USA.

Stefano BertozziSchool of Public Health, University of California Berkeley, Berkeley, CA, USA.

Will LucasCarhart-Harris Lab, University of California San Francisco, San Francisco, CA, USA.

Robin Carhart HarrisCarhart-Harris Lab, University of California San Francisco, San Francisco, CA, USA.

Dacher KeltnerUC Berkeley, Center for the Science of Psychedelics, University of California, Berkeley, Berkeley, USA.

Charles RaisonDepartment of Psychiatry, University of Wisconsin-Madison, Madison, WI, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Psychiatric trials typically define success as symptom reduction, yet patients prioritize meaning, vitality, and functioning. This imbalance undervalues experiential benefits, distorting clinical, policy, and FDA decisions. Psychedelic trials illustrate this, where robust well-being gains sometimes accompany modest symptom effects. We argue well-being should be elevated to co-primary endpoint status, propose a Delphi-developed consensus well-being instrument with rigorous validation, and outline guardrails preventing approval of therapies that worsen the underlying condition.

Identifiers

PMID42581324

DOI10.1038/s44184-026-00234-1

PMCPMC13462081

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LicenceCC BY

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.