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 L. Raison
npj Mental Health Research August 6, 2026 DOI: 10.1038/s44184-026-00234-1 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Theoretical or philosophical paper Peer reviewed |
|---|---|
| Key points | Argues that psychiatric trials' focus on symptom reduction undervalues patient-prioritized outcomes like meaning, vitality, and functioning, and proposes making well-being a co-primary endpoint, developing a Delphi consensus well-being instrument, and adding guardrails against approving therapies that worsen the underlying condition. |
Abstract
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.