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Active suicidal ideation during clinical antidepressant trials
Elizabeth D Ballard1, Sam L Snider1, Allison C Nugent1
1Experimental Therapeutics & Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD 20892, USA.
Abstract:
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.
Insights
Active suicidal ideation (SI) in patients with major depressive disorder or bipolar disorder is often unstable, fluctuating significantly over short periods. This suggests research in these populations is feasible with careful monitoring.
Area of Science:
- Psychiatry
- Neuroscience
- Clinical Psychology
Background:
- Suicidal patients are frequently excluded from psychiatric clinical trials and neurobiological research.
- Understanding the presence and stability of active suicidal ideation (SI) is crucial for including these patients in research.
Purpose of the Study:
- To evaluate the prevalence, impact, and temporal stability of active SI in patients with major depressive disorder (MDD) or bipolar disorder (BD) participating in antidepressant trials.
- To assess the feasibility of conducting neurobiological research in patients experiencing active SI.
Main Methods:
- Review of 14 clinical trials involving 269 participants with MDD or BD.
- Identification and tracking of active SI throughout study participation.
- Evaluation of SI stability using intraclass correlation coefficients (ICCs) and comparison with other depressive symptoms.
Main Results:
- 23% of participants (63/269) reported active SI at some point during the trials.
- A significant proportion of participants experiencing active SI also underwent neuroimaging or polysomnography.
- Only 39% of patients continued to report active SI after three days without additional treatment, indicating high fluctuation.
- Intraclass correlation coefficients (ICCs) were not significant for SI or pessimism, unlike other depressive symptoms.
Conclusions:
- Active SI in patients with MDD or BD is often transient and highly variable.
- Neurobiological research can be conducted in patients with active SI, provided careful observation and monitoring protocols are in place.
- Active SI and pessimism represent potentially unstable symptom clusters in these patient populations.