Innovations In Clinical Neuroscience

MAR-APR 2018

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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42 ICNS INNOVATIONS IN CLINICAL NEUROSCIENCE March-April 2018 • Volume 15 • Number 3–4 O R I G I N A L R E S E A R C H Clearly, prescribing medication to manage anxiety in patients who don't have disruptive symptoms would not be justified. To address this issue, the DSM-IV-TR Criterion E differentiated "true" GAD from nonpathological anxiety and required that the persistent anxiety or worry must cause clinically significant distress. 1 The recently adapted DSM-5 criteria retained this requirement as Criterion D. 2 Clearly, all of the enrolled patients in this study met the DSM distress criterion so that there was no doubt that they needed a new treatment intervention. Our data do not address milder illness and cannot inform whether patients with milder GAD can be differentiated from normally anxious people with nonpathological anxiety and would benefit from earlier treatment intervention. The digital revolution has made it possible to conduct remote independent assessments of patients. In this study, we used audio-digital recordings as a site-independent "dual" review method to assess patients with GAD as part of the eligibility procedures for a clinical trial. The second opinions were obtained from site-independent clinical experts who received the audio-recorded data in lieu of conducting a second, live interview. A possible limitation of this method is that the precision of the second independent opinion relies on the quality of the primary site-based clinician interview. Based on our experience with surveillance strategies, the use of audio recording actually improves the quality of site-based interviews. 19,20 CONCLUSION The audio-recording method is a time-efficient, pragmatic approach that minimizes patient burden because it does not require longer clinic times and extra scheduling to conduct a second live clinical assessment. This method might have broader utility in clinical practice where second opinions might be desirable but not always feasible. CONTRIBUTORS Dr. Targum participated in the design, implementation, and analysis of the original study and conceived, analyzed, and wrote the current analysis reported in this manuscript. Dr. Binneman, Dr. Simen, Dr. Whitlock, and Ms. Zumpano participated in the design, implementation, monitoring, and analysis of the study and review of the manuscript on behalf of the sponsor, Pfizer, and communicated with Dr. Targum about the data analysis for this current manuscript. Dr. Murphy and Mr. Khan assisted with the collection, collation, and analysis of the data and assisted with the preparation of the final manuscript. REFERENCES 1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. American Psychiatric Press, Inc; Arlington, VA; 1994. 2. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Arlington, VA: American Psychiatric Press Inc; 2013. 3. Greenberg PE, Sisitsky T, Kessler RC, et al. The economic burden of anxiety disorders in the 1990s. J Clin Psychiatry. 1999;60(7):427–435. 4. Wittchen HU. Generalized anxiety disorder: prevalence, burden, and cost to society. Depress Anxiety. 2002;16(4):162–171. 5. Barrera T, Norton P. Quality of life impairment in generalized anxiety disorder, social phobia, and panic disorder. J Anxiety Disord. 2009;23(8):1086– 1090. 6. Hoge EA, Ivkovic A, Fricchione Gl. Generalized anxiety disorder: diagnosis and treatment. BMJ. 2012;345:e7500. 7. Bandelow B, Boerner R, Kasper S, et al. The diagnosis and treatment of generalized anxiety disorder. Dtsch Arztebl Int. 2013;110(17):300–9. 8. Struzik L, Vermani M, Coonerty-Femiano A, Katzman MA. 2004. Treatments for generalized anxiety disorder. Expert Rev Neurother. 2004;4(2):285–294. 9. Kavan MG, Elsasser GN, Barone EJ. 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Psychopharmacol Bull. 1981:100–101. 15. Hamilton MA. The assessment of anxiety states by rating. Br J Med Psychol. 1959;23:50–55. 16. Guy W. ECDEU Assessment Manual for Psychopharmacology, Revised. US Department of Health, Education, and Welfare (DHEW) Publication ADM-76-338).1972;218–222. 17. Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Int Med. 2006;166(10):1092–7. 18. Targum, SD, Houser C, Northcutt J, et al. A Structured Interview Guide for Global Impressions: reliability and validity for CNS trials. Ann Gen Psychiatry. 2013;12(1):2. 19. Targum SD, Pendergrass JC. Site-independent confirmation of subject selection for CNS trials: "dual" review using audio-digital recordings. Ann Gen Psychiatry. 2014;13:21. 20. Targum SD, Pendergrass JC, Toner C, et al. Audio- digital recordings used for independent confirmation of site-based MADRS interview scores. Eur Neuropsychopharmacol. 2014;24(11):1760–6. 21. NICE Clinical Guideline CG113. 2011. Generalized anxiety disorder and panic disorder (with or without agoraphobia) in adults: management in primary, secondary and community care. NICE (CG113) 22. World Health Organization (WHO) Obesity: preventing and managing the global epidemic. report of a WHO Consultation. WHO Technical Report Series 894. Geneva: World Health Organization; 2000. 23. Kessler RC, Gruber M, Hettema JM, et al. Co-morbid major depression and generalized anxiety disorders in the National Comorbidity Survey follow-up. Psychol Med. 2008;38(3):365–374. 24. Andrews G, Hobbs MJ, Borkovec TD, et al. Generalised worry disorder: a review of DSM-IV generalised anxiety disorder and options for DSM-V. Depress Anxiety. 2010;27(2):134–47. 25. Beesdo K, Pine DS, Lieb R, Wittchen HU. Incidence and risk patterns of anxiety and depressive disorders and categorization of generalized anxiety disorder. Arch Gen Psychiatry. 2010;67(1):47–57. ICNS

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