T Roehrs1, J C Verster2, G Koshorek3, D Withrow3, T Roth4. 1. Sleep Disorders & Research Center, Henry Ford Hospital, Detroit, MI, USA; Dept. Psychiatry, SOM, Wayne State University, Detroit, MI, USA. Electronic address: troehrs1@hfhs.org. 2. Division of Pharmacology, Utrecht University, Utrecht, The Netherlands; Institute for Risk Assessment Sciences, Utrecht University, Utrecht, The Netherlands; Centre for Human Psychopharmacology, Swinburne University, Melbourne, Australia. 3. Sleep Disorders & Research Center, Henry Ford Hospital, Detroit, MI, USA. 4. Sleep Disorders & Research Center, Henry Ford Hospital, Detroit, MI, USA; Dept. Psychiatry, SOM, Wayne State University, Detroit, MI, USA.
Abstract
OBJECTIVES: To address the question of how representative subjects studied in hypnotic clinical trials are of the broader insomnia population, this study assessed initial contact rates and reasons for inclusion and exclusion during recruitment to an efficacy trial and to a safety trial of Food & Drug Administration (FDA) approved hypnotics. METHODS: Otherwise heathy persons meeting Diagnostic Statistical Manual, Fourth Edition, Revised (DSM-IVR) criteria for insomnia were recruited. In one study, persons 32-65 yrs, were invited to a 12 month trial of nightly use of zolpidem or placebo. In the other, persons 21-64 yrs with driver's licenses were recruited to test the effects of a hypnotic on live on-the-road driving ability. In both studies screening was conducted through an initial telephone interview followed by a clinic visit. RESULTS: In the United States (US) study 13% (n = 410) of 3180 initial contacts and in the Netherlands (NL) study 67% (n = 53) of the 79 initial contacts proceeded to the clinic visit. Of those at clinic 25% of US and 37% of NL participants failed to meet additional insomnia criteria. Mental health exclusions accounted for 24% of US and 23% of NL participants and medical problems accounted for 23% of US and 9% NL exclusions. Finally 20% of US and 26% of NL participants were excluded for drug use/abuse histories. After all screening 4% of the initial US contacts and 0% of the NL contacts entered the study. CONCLUSIONS: These data suggest persons entering insomnia hypnotic clinical trials are a highly selected sample that is unlikely to be representative of the broad insomnia population or the population of potential medication users.
OBJECTIVES: To address the question of how representative subjects studied in hypnotic clinical trials are of the broader insomnia population, this study assessed initial contact rates and reasons for inclusion and exclusion during recruitment to an efficacy trial and to a safety trial of Food & Drug Administration (FDA) approved hypnotics. METHODS: Otherwise heathy persons meeting Diagnostic Statistical Manual, Fourth Edition, Revised (DSM-IVR) criteria for insomnia were recruited. In one study, persons 32-65 yrs, were invited to a 12 month trial of nightly use of zolpidem or placebo. In the other, persons 21-64 yrs with driver's licenses were recruited to test the effects of a hypnotic on live on-the-road driving ability. In both studies screening was conducted through an initial telephone interview followed by a clinic visit. RESULTS: In the United States (US) study 13% (n = 410) of 3180 initial contacts and in the Netherlands (NL) study 67% (n = 53) of the 79 initial contacts proceeded to the clinic visit. Of those at clinic 25% of US and 37% of NL participants failed to meet additional insomnia criteria. Mental health exclusions accounted for 24% of US and 23% of NL participants and medical problems accounted for 23% of US and 9% NL exclusions. Finally 20% of US and 26% of NL participants were excluded for drug use/abuse histories. After all screening 4% of the initial US contacts and 0% of the NL contacts entered the study. CONCLUSIONS: These data suggest persons entering insomnia hypnotic clinical trials are a highly selected sample that is unlikely to be representative of the broad insomnia population or the population of potential medication users.
Authors: Andrew D Krystal; Alan Lankford; H Heith Durrence; Elizabeth Ludington; Philip Jochelson; Roberta Rogowski; Thomas Roth Journal: Sleep Date: 2011-10-01 Impact factor: 5.849
Authors: W Joseph Herring; Kathryn M Connor; Neely Ivgy-May; Ellen Snyder; Ken Liu; Duane B Snavely; Andrew D Krystal; James K Walsh; Ruth M Benca; Russell Rosenberg; R Bart Sangal; Kerry Budd; Jill Hutzelmann; Heather Leibensperger; Samar Froman; Christopher Lines; Thomas Roth; David Michelson Journal: Biol Psychiatry Date: 2014-10-23 Impact factor: 13.382
Authors: Thomas Roth; Janet M Price; David A Amato; Robert P Rubens; James M Roach; Thomas J Schnitzer Journal: Prim Care Companion J Clin Psychiatry Date: 2009
Authors: Hendrikje Huls; Smedra Abdulahad; Marlou Mackus; Aurora J A E van de Loo; Timothy Roehrs; Thomas Roth; Joris C Verster Journal: J Clin Med Date: 2018-08-08 Impact factor: 4.241
Authors: Jill S Borchert; Bo Wang; Muzaina Ramzanali; Amy B Stein; Latha M Malaiyandi; Kirk E Dineley Journal: J Med Internet Res Date: 2019-11-08 Impact factor: 5.428
Authors: Joris C Verster; Aurora Jae van de Loo; Sally Adams; Ann-Kathrin Stock; Sarah Benson; Andrew Scholey; Chris Alford; Gillian Bruce Journal: J Clin Med Date: 2019-12-06 Impact factor: 4.241