Methodological Question Being Addressed: What is the meaning of severity and response scores on the SANS? Introduction: The treatment and measurement of negative symptoms are currently at issue in schizophrenia, but the clinical meaning of symptom severity and change are unclear. Thus the current study aims to offer a clinically meaningful interpretation of severity and change scores on the Scale for the Assessment of Negative Symptoms(SANS).Methods: 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 medication. Results: Across visits, CGI-S ratings of ‘not ill’ linked to SANS scores of 0-13, and ranged to ‘extreme’ ratings thatlinked to SANS scores of 102-105. The relationship between the CGI-S and the SANS severity scores assumed alinear trend (1= 0-13, 2=15-56, 3= 37-61, 4= 49-66, 5= 63-75, 6= 79-89, 7= 102-105). Similarly the relationshipbetween CGI-I ratings and SANS percentage change followed a linear trend. For instance, CGI-I ratings of ‘Very much improved’ linked to SANS percent change of -90 to -67, ‘much improved’ with -50 to -42, and ‘minimallyimproved’ with -21 to -13.Conclusion: The current results 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. Disclosures: In the last three years Stefan Leucht received speaker/consultancy/advisory board honoraria fromSanofiAventis, BMS, Alkermes, EliLilly, Essex Pharma, AstraZeneca, Janssen/Johnson and Johnson,Lundbeck Institute, Medavante and Pfizer. EliLilly provided medication for a clinical trial with Stefan Leucht as theprincipal Investigator. Stefan Leucht received funding from the German Ministry of Education and Research for aclinical trial and systematic review. The American College of Neuropsychopharmacology has provided a travelgrant to attend the ACNP meeting in 2010. Stephen Levine has received research support, and/or consultancy feesand/or travel support from F. Hoffmann-La Roche and Eli Lilly.
|Number of pages||1|
|State||Published - 2012|
|Event||International Society for CNS Clinical Trials and Methodology - Marina del Rey, United States|
Duration: 1 Oct 2012 → 3 Oct 2012
|Conference||International Society for CNS Clinical Trials and Methodology|
|City||Marina del Rey|
|Period||1/10/12 → 3/10/12|