spacer
home > > summer 2009 > warning signs
PUBLICATIONS


Warning Signs

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.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

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.

spacer
James C Mundt
spacer
spacer
spacer
Alan J Gelenberg
spacer
spacer
spacer
John H Greist
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Discussing developments on Highly Potent APIs with industry expert, Richard Arnett for the HPAPI USA conference 2019

Ahead of the 2019 HPAPI USA Conference taking place in Boston on 21st – 22nd October, SMi caught up with Richard Arnett, Manager, Industrial Hygiene, Pharmascience who is speaking on Day Two of the agenda. Richard shared his thoughts on how the industry has developed and briefly touched on what he will be discussing in October.
More info >>

White Papers

The Impact of Components on Drug Quality and Risk Mitigation

West Pharmaceutical Services, Inc.

Expectations for quality by regulatory agencies are increasing at a very fast pace, especially for prefilled drug delivery formats, thanks to increased focus on reducing risk to patient safety. The trend has resulted in delays for new drug applications, more recalls of marketed products and even drug shortages if the container system and drug contents are suspect for quality issues. The pharmaceutical market is now requiring manufacturers of containers and components to meet new expectations with a quality culture and very high product reliability. The need to bridge the gap and provide superior quality products has been a driver for manufacturing technology investments, more robust control strategies and the introduction of next generation elastomer components.
More info >>

 
Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement