Stephen Z Levine1, Stefan Leucht. 1. University of Haifa, Department of Community Mental Health, Israel. stezlev@gmail.com
Abstract
BACKGROUND: The treatment and measurement of negative symptoms are currently at issue in schizophrenia, but the clinical meaning of symptom severity and change is unclear. AIM: To offer a clinically meaningful interpretation of severity and change scores on the Scale for the Assessment of Negative Symptoms (SANS). METHOD: Patients were intention-to-treat participants (n=383) in two double-blind randomized placebo-controlled clinical trials that compared amisulpride with placebo for the treatment of predominant negative symptoms. Equipercentile linking was used to examine extrapolation from (a) CGI-S to SANS severity ratings, and (b) CGI-I to SANS percentage change (n=383). Linking was conducted at baseline, 8-14 days, 28-30 days, and 56-60 days of the trials. RESULTS: Across visits, CGI-S ratings of 'not ill' linked to SANS scores of 0-13, and ranged to 'extreme' ratings that linked to SANS scores of 102-105. The relationship between the CGI-S and the SANS severity scores assumed a linear trend (1=0-13, 2=15-56, 3=37-61, 4=49-66, 5=63-75, 6=79-89, 7=102-105). Similarly the relationship between CGI-I ratings and SANS percentage change followed a linear trend. For instance, CGI-I ratings of 'very much improved' were linked to SANS percent changes of -90 to -67, 'much improved' to -50 to -42, and 'minimally improved' to -21 to -13. CONCLUSIONS: The current results uniquely contribute to the debate surrounding negative symptoms by providing clinical meaning to SANS severity and change scores and so offer direction regarding clinically meaningful response cut-off scores to guide treatment targets of predominant negative symptoms.
RCT Entities:
BACKGROUND: The treatment and measurement of negative symptoms are currently at issue in schizophrenia, but the clinical meaning of symptom severity and change is unclear. AIM: To offer a clinically meaningful interpretation of severity and change scores on the Scale for the Assessment of Negative Symptoms (SANS). METHOD:Patients were intention-to-treat participants (n=383) in two double-blind randomized placebo-controlled clinical trials that compared amisulpride with placebo for the treatment of predominant negative symptoms. Equipercentile linking was used to examine extrapolation from (a) CGI-S to SANS severity ratings, and (b) CGI-I to SANS percentage change (n=383). Linking was conducted at baseline, 8-14 days, 28-30 days, and 56-60 days of the trials. RESULTS: Across visits, CGI-S ratings of 'not ill' linked to SANS scores of 0-13, and ranged to 'extreme' ratings that linked to SANS scores of 102-105. The relationship between the CGI-S and the SANS severity scores assumed a linear trend (1=0-13, 2=15-56, 3=37-61, 4=49-66, 5=63-75, 6=79-89, 7=102-105). Similarly the relationship between CGI-I ratings and SANS percentage change followed a linear trend. For instance, CGI-I ratings of 'very much improved' were linked to SANS percent changes of -90 to -67, 'much improved' to -50 to -42, and 'minimally improved' to -21 to -13. CONCLUSIONS: The current results uniquely contribute to the debate surrounding negative symptoms by providing clinical meaning to SANS severity and change scores and so offer direction regarding clinically meaningful response cut-off scores to guide treatment targets of predominant negative symptoms.
Authors: Arthur L Brody; Todd Zorick; Robert Hubert; Gerhard S Hellemann; Shabnam Balali; Sarah S Kawasaki; Lizette Y Garcia; Ryutaro Enoki; Paul Abraham; Paulina Young; Charles McCreary Journal: Nicotine Tob Res Date: 2016-08-03 Impact factor: 4.244
Authors: Toshi A Furukawa; Mirjam Reijnders; Sanae Kishimoto; Masatsugu Sakata; Robert J DeRubeis; Sona Dimidjian; David J A Dozois; Ulrich Hegerl; Steven D Hollon; Robin B Jarrett; François Lespérance; Zindel V Segal; David C Mohr; Anne D Simons; Lena C Quilty; Charles F Reynolds; Claudio Gentili; Stefan Leucht; Rolf R Engel; Pim Cuijpers Journal: Epidemiol Psychiatr Sci Date: 2019-03-14 Impact factor: 6.892