The assessment of suicidality in psychiatric trials: a protocol for a scoping review

INTRODUCTION: Suicide is one of the leading causes of death worldwide, especially in patients with mental health disorders. Suicidality is an important outcome for patients in psychiatric randomised clinical trials. The aim of this scoping review is to assess whether and how psychiatric trials assess suicidal ideation, suicide attempts, and suicides. METHODS: This is a protocol for a scoping review. We will conduct a search of high-impact journals for randomised clinical trials published since January 2022 that include mental health patients, irrespective of the intervention type. We will assess if and how psychiatric trials assess suicidal ideation, suicide attempts, and suicides. DISCUSSION: This scoping review will be the first to examine how suicidality is assessed in contemporary randomised clinical trials. In combination with the PIO-Psych Initiative, this scoping review will ultimately guide future researchers in selecting patient-important outcomes and inform clinical research practice. However, the focus on high-impact journals may limit the generalisability of the findings. SCOPING REVIEW REGISTRATION: This scoping review is part of a project that has been prospectively registered on the COMET website ( https://comet-initiative.org/Studies/Details/3125 ).