Assessment of suicidal ideation and behavior in clinical trials: challenges & controversies

Author(s): Glenn Melvin

The association between several psychoactive medications and suicidal adverse events, as well as the recent focus on treatment of suicidal behaviors, has resulted in increased attention on the assessment of suicidal ideation and behavior within clinical trials. Measurement of suicidal adverse events is now required in clinical trials of a range of medications. The Columbia Suicide Severity Rating Scale is the leading measure of suicidal adverse events. It is brief, measures both suicidal ideation and behavior, contains definitions of each term and has promising psychometric properties. While such measures may assist clinical trial staff, suicidal events remain a challenge to assess. Clinical trial design features from studies of interventions for suicidal patients may guide the design of trials in which assessment of suicidal adverse events is now required, including patient selection, safety plans for at-risk patients, flexible treatment algorithms and clear assessment protocols and referral pathways.