Current Clinical Trials to Treat Anxiety Disorders in the Elderly: A Registry-Based Review

Background/Objectives: Anxiety disorders in people over 65 y of age are common. Treatment of those disorders is often based on studies involving much younger patients. Experience shows that those treatments are regularly ineffective in the elderly, due to differences in physiology and the disparate etiology of the disease. Here, we examine current trends in research to generate data for evidence-based approaches to treat anxiety disorders in the elderly. Our objective was to evaluate the scope, methodological characteristics, and therapeutic focus of current clinical trials for anxiety disorders in the elderly, and to determine whether the existing evidence pipeline is likely to meet the substantial unmet need for effective and well-tolerated treatments. Methods: We searched clinicaltrials.gov for studies addressing "Anxiety disorder" and related readouts and selected those studies that included patients older than 65 y, and that had anxiety measures as primary or secondary endpoints. Results: We find that over 99% of clinical "anxiety" trials exclude patients older than 65 y. Sixty-six trials fulfilled our inclusion criteria. Trials specifically recruiting the elderly are a rare exception. Unexpectedly, only 10 "anxiety" trials are sponsored by the pharmaceutical industry, despite the potential rewards in such investments. Discussion and Conclusions: Although most clinical trials are registered in clinicaltrials.gov., our work is limited by the fact that not all clinical trials carried out world-wide are included in that database. Our findings indicate that ongoing clinical research supporting evidence-based recommendations for the treatment of anxiety in the elderly is scarce. Detailed secondary analysis of clinical trial results for the efficacy and safety of anxiolytics in various age cohorts may at least be a useful instrument for hypothesis generation, to trigger additional clinical research specifically designed to address anxiety treatment in the elderly.