From the FDA Drug Label
WARNINGS Clinical Worsening and Suicide Risk — Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases
The FDA drug label does not answer the question.
From the Research
Institutional Review Boards (IRBs) do not universally require the exclusion of participants at high risk of suicide from all research studies, but they often do require special protections and considerations for these individuals. The decision depends on the nature of the research, risk-benefit ratio, and available safeguards. For studies specifically investigating suicide prevention or treatments for suicidal individuals, excluding such participants would defeat the purpose of the research. In these cases, IRBs typically require robust safety protocols including regular suicide risk assessments, clear crisis intervention procedures, 24-hour emergency contact information, and qualified mental health professionals on the research team, as highlighted in a study published in the Journal of Abnormal Psychology in 2020 1.
Some key considerations for IRBs include:
- The potential risks and benefits of the research for participants at high risk of suicide
- The availability of adequate safety measures, such as regular monitoring and crisis intervention procedures
- The potential impact of the research on the participant's mental health and well-being
- The need for qualified mental health professionals to be involved in the research team
For studies not directly related to suicide or mental health, IRBs may recommend exclusion of high-risk individuals if participation could exacerbate suicidal thoughts or if adequate safety measures cannot be implemented. A study published in Psychiatry Research in 2014 found that suicide precautions have a protective effect against inpatient suicides, particularly for those with depression-related symptoms 2. IRBs follow the ethical principles of beneficence (maximizing benefits while minimizing harm) and justice (fair distribution of research benefits and burdens), which means they aim to protect vulnerable participants while also ensuring they have access to potentially beneficial research.
Recent studies, such as one published in Early Intervention in Psychiatry in 2015, have shown that online interventions can be a safe and acceptable way to deliver support to at-risk adolescents, as long as adequate safety procedures are in place 3. Another study published in Focus in 2020 emphasized the importance of suicide risk assessment and management in clinical research, highlighting the need for researchers to be aware of the unique considerations associated with suicide risk assessment in a research context 4. Overall, the goal of IRBs is to balance the need to protect vulnerable participants with the need to advance knowledge and understanding of suicide prevention and treatment.