Suicidal patients are often excluded from clinical trials of psychiatric medications and from investigations using neurobiological techniques. To evaluate the presence, impact, and stability of active suicidal ideation (SI) across a range of antidepressant trials, we reviewed 14 clinical trials conducted in patients with either major depressive disorder (MDD) or bipolar disorder (BD) (N = 269). Active SI at any time point in the clinical trial was identified and linked to participation in other research procedures. Stability of active SI across subsequent days was evaluated using intraclass correlation coefficients (ICCs) and compared to other depressive symptoms. Across 14 clinical trials, 63 participants (23%) reported active SI at some point during study participation. Of these participants, 33 completed a neuroimaging procedure and 16 completed polysomnography within a week of active SI. When active SI was subsequently assessed, only 39% of patients continued to report active SI after three days of assessment, despite receiving no additional treatment. ICCs were not significant for either SI or pessimism; other depressive symptoms showed stability over time. The results suggest that research can be conducted in depressed patients with active SI if such research coincides with careful observation. Active SI and pessimism may be particularly vulnerable to fluctuation.
Trial registration: ClinicalTrials.gov NCT00024635.
Keywords: Clinical trials; Depression; Neuroimaging; Safety; Suicidal ideation; Suicide.
Published by Elsevier B.V.