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European Pharmaceutical Contractor
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Concerns about increased risk of suicidal ideation and behaviours (suicidality) in patients taking antidepressants and other classes of medication have led to suicidality label warnings. Even safety profiles of drugs that do not cross the blood-brain barrier – previously thought to have minimal effects on the central nervous system – are being reconsidered. These medications may influence other chemicals that do enter the brain, thereby affecting emotions, thoughts and behaviours. Medicines as diverse as those that treat acne, allergy, asthma, bacterial infections, epilepsy, heartburn, high cholesterol, hypertension, insomnia, obesity, pain and substance misuse disorders (including smoking), may affect or even cause suicidality.
The low frequency of suicidality even in psychiatric disorders and the limited reliability and accuracy of instruments to assess suicidality in clinical settings adds complexity to the issue. Clinicianadministered assessments are plagued by inter- and intra-rater variability, which can be even greater when clinicians have minimal mental health training. Even after extensive training, deterioration of rater skills over time has been documented. Such variability decreases the reliability and accuracy of these assessments and, therefore, their value in detecting suicidality signals and ensuring patient safety.
This article addresses safety concerns, monitoring requirements and available methods for assessing and monitoring suicidality in clinical drug trials. |
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James C Mundt is Research Scientist and Vice President of R&D at Healthcare Technology Systems. He received a PhD in Experimental Psychology from the University of Wisconsin, Madison in 1991. His basic research interests involve the interface between technology and people, particularly as they relate to perception, attention, cognition, performance measurement and scale development. He has been engaged in the development of interactive voice response systems to facilitate research data collection methods since 1994. Applied interests include automated assessment and treatment of behaviour health issues involved in alcohol and substance abuse disorders, clinical computing systems involved in clinical trial outcomes, public information and educational systems regarding Alzheimer’s disease and other dementias, and automated telephone systems for neuropsychological assessment of cognitive functioning.
Alan J Gelenberg, MD is President and CEO of Healthcare Technology Systems. Since 1987, he has been Editor-in-Chief of the Journal of Clinical Psychiatry. A Clinical Professor at the University of Wisconsin, Madison, he is founding author of Biological Therapies in Psychiatry Newsletter, now in its 31st year. For 18 years, he was Professor and Head of the University of Arizona’s Department of Psychiatry, where he remains Professor Emeritus. Alan has been on the Harvard, Massachusetts General Hospital, and MIT faculties. He helped create the ASEX scale to track sexual side effects of antidepressants and now works on electronic and other strategies to enhance clinical trial design. He is helping to create an interactive voice response (IVR) version of the Columbia suicide-assessment scale.
John H Greist, MD, is a Distinguished Senior Scientist at the Madison Institute of Medicine, and Clinical Professor of Psychiatry at the University of Wisconsin School of Medicine and Public Health. He is also Co-Founder of the Lithium Information Center, Bipolar Disorders Treatment Information Center and the Obsessive Compulsive Information Center, at the Madison Institute of Medicine. His major clinical and research interests are anxiety and mood disorders, psychopharmacology, behaviour therapy, and clinical applications of computing. John received his BA from Princeton University in 1961 and his MD from Indiana University in 1965. Following a medical internship at the University of Wisconsin, he completed residency training in internal medicine at the University of Wisconsin, where he was chief resident in 1969-1970. In his final year of psychiatry residency at the University of Wisconsin (1970-1971), he was a Fellow in child psychiatry; he joined the faculty of the department in 1971. He is board certified in psychiatry. |
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BIO-Europe Spring® 2012 — 6th International Partnering Conference
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