Skip to main content
. Author manuscript; available in PMC: 2012 Dec 1.
Published in final edited form as: Clin Ther. 2011 Dec;33(12):B16–B39. doi: 10.1016/j.clinthera.2011.11.016

Table 5. Relapse Definition in Trials Comparing Oral Second-Generation Antipsychotics to Placebo or to First-Generation Antipsychotics.

Study Domains of Relapse Definition
Hospitalization CGI 13 PANSS 12 or BPRS 29 Clinical Symptoms and Others
Dellva 1997 37; Tran 1998 38; De Sena 2003 39 hospitalization - - -
Cooper 2000 40 a,b,c hospitalization CGI-S ↑ ≥2 2 of BPRS-P subscale ↑≥2 -
CGI-S ↑ ≥2 2 of BPRS-P subscale ↑≥2 -
CGI-S ≥6 - Need observation if patient is inpatient
Csernansky 2002 41; Schooler 2005 42 hospitalization CGI-C ≥6 PANSS-T ↑≥25%, or +10 Self-injury, suicidal/homicidal ideation, violence
Arato 2002 43 - CGI-C ≥6 PANSS P7+/-G8 ≥6 in 2 successive days -
Beasley 2003 44 hospitalization - any BPRS-P subscale ≥4 and BPRS specific subscale ↑≥2, or positive subscale↑≥4 Completed suicide or a serious suicide attempt
Piggot 2003 45 - CGI-C ≥5 PANSS P7/G8 ≥5 on 2 successive days or PANSS-T ↑ ≥20% -
Lieberman 2003 46; Green 2006 47 - CGI-S ≥4 Any of PANSS P1, 2, 3, 5, 6 ≥4 -
Lecrubier 2006 48 hospitalization - PANSS-T ↑≥30% -
Peuskins 2007 49 hospitalization CGI-C ≥6 PANSS-T ↑≥30% Need for additional AP
Kramer 2007 50 hospitalization CGI-S ≥4 or 3→5 PANSS-T ↑≥25% or 10 points, or specific PANSS item 3→5 or 4→6 Self-injury, suicidal/homicidal ideation, violence
Gaebel 2007 51 a - CGI-C ≥6 PANSS-P ↑>10 GAF ↓>20
Kane 2008 52 hospitalization CGI-S↑ ≥2 - Discontinuation due to lack of efficacy
Crespo-Facorro 2010 53 hospitalization CGI-S ≥6 and CGI-C ≥6 Any key BPRS subscale ≥5 Completed suicide attempt

BPRS-P=brief psychotic rating scale positive symptoms score; CGI-C/S=clinical global impression change/severity score; GAF=global assessment of functioning; PANSS-P/T=positive and negative symptom scale positive/total score; ↑=increase; ↓=decrease;

a

patients required to meet all criteria concurrently;

b

CGI and BPRS criteria both required to be present at 2 consecutive assessments over 3 days;

c

hospitalization, CGI and BPRS criteria required to be present at the same assessment time point;

d

all criteria required to be present at two consecutive visits