Moving Forward in Clinical Trials for Late-Life Disorders

New clinical trials for the management of psychiatric disorders in older adults are responding to the pressing need to reduce the burden of mental illness in our aging population. This endeavor most certainly calls for novel ideas to bring innovative treatment strategies from the research setting to the community. Although recent research has systematically explored a variety of psychotropic agents, there remains a need to carefully evaluate our methods of clinical assessment and response measures to optimally tailor these trials for the older generation. Psychiatrists in the care of older adults have long recognized that this population does not readily express or acknowledge psychiatric symptoms and often avoids seeking mental health professionals, a problem that appears most pronounced among elderly men. Certainly there is a social influence at work, as older adults are more likely to view psychiatric symptoms as a sign of weakness and a source of embarrassment. Furthermore, neuroscience research has demonstrated age-related changes in the processing of emotion at the neural level as well as an inability to visually recognize emotional changes in others. Regardless of the many processes afoot, it is evident that tailored techniques for the older adult may be needed to successfully detect target symptoms. Such assessments unfortunately may not be easily incorporated into clinical trials. For example, in everyday clinical practice, one quickly finds that an unhurried interview with an older adult is unlikely to quickly yield a cohesive “history of present illness” for a specific psychiatric disorder. Similarly, conducting a standardized rating scale may not optimally capture the older adult’s clinical condition. Most frequently, a willing listener in a clinical interview with an older adult will experience a tangential narration of personal stories, evoking a variety of images, scenes, and snippets of earlier triumphs and tragedies as well as current worries and challenges. Sifting through the content of such a narrative may in fact be the best way to detect evidence of an underlying mood or anxiety disorder. Indeed, given the hesitancy of older adults to directly report psychiatric symptoms, one may argue that a nonthreatening genial conversation is the only way to glean the true nature of their mental state. This type of method does not readily lend itself to rater training and interrater reliability techniques, but may be an invaluable means of identifying target conditions for clinical interventions. Such qualitative interpretations derived out of unstructured dialogue comprise the foundation of clinical decision-making in daily practice, yet this very process tends to defy the standardization necessary for clinical trial methods of assessment. Current clinical trials have sought, to the extent possible, to help reduce the burden of mental illness in late life by testing new medications, yet the ability to detect their benefits is directly tied to the accuracy of clinical assessment. Hence, the field may benefit from stepping back a moment and asking the most fundamental of questions: How can we improve our detection of target symptoms so that we know when we have achieved a response? How much do the patient’s