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Well-being as a primary endpoint in clinical trials: a call for consensus
Elliot Marseille1, Hannes Kettner2, Tyrone J Sgambati3
1Collaboration for the Economics of Psychedelics, University of California Berkeley, Berkeley, CA, USA. emarseille1@berkeley.edu.
Npj Mental Health Research
|August 12, 2026
Summary
Psychiatric clinical trials often overlook patient-valued well-being, focusing instead on symptom reduction. This study advocates for elevating well-being as a co-primary endpoint in psychiatric research and treatment.
Area of Science:
- Psychiatry and Mental Health Research
- Clinical Trial Design
- Patient-Reported Outcomes
Background:
- Current psychiatric trials primarily measure success via symptom reduction.
- This focus neglects crucial patient-centered outcomes like meaning, vitality, and functioning.
- This imbalance impacts clinical practice, policy, and regulatory decisions, including those by the Food and Drug Administration (FDA).
Purpose of the Study:
- To address the imbalance between symptom reduction and patient-valued well-being in psychiatric trials.
- To advocate for well-being to be recognized as a co-primary endpoint in psychiatric research.
- To propose a validated instrument for measuring well-being in clinical settings.
Main Methods:
- Literature review and analysis of current psychiatric trial endpoint methodologies.
- Proposal of a consensus-based well-being instrument developed using the Delphi method.
- Outline of regulatory guardrails for therapy approval.
Main Results:
- Psychedelic trials demonstrate that significant well-being improvements can occur alongside modest symptom reduction.
- A Delphi-developed instrument for measuring well-being is proposed with plans for rigorous validation.
- The study highlights the need for a paradigm shift in outcome measurement.
Conclusions:
- Elevating well-being to co-primary endpoint status is essential for patient-centered psychiatric care.
- A validated well-being instrument is crucial for accurate assessment in clinical trials.
- Guardrails are needed to ensure therapies improve overall condition without causing harm.
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