Validation of the behavioural activity rating scale (BARS) TM : anovelmeasureofactivityinagitatedpatients R.H. Swift a ,E.P.Harrigan b ,J.C.Cappelleri a, *, D. Kramer c ,L.P.Chandler d a Pfizer Inc, Global Research and Development, Eastern Point Road, Groton, CT 06340, USA b Sepracor Inc, Marlboro, MA 01752, USA c PRA International, Lenexa, KS 66219, USA d Kula,HI96790,USA Received 9 February 2001; received in revised form 28 September 2001; accepted 22 October 2001 Abstract WereportpsychometricresultsoftheBehaviouralActivityRatingScale(BARS TM )usingdatafromthreePhaseIIIclinicaltrials ofintramuscularziprasidoneinacutelyagitatedpatientswithpsychosis(Studies1and2)orinstablepsychoticpatients(Study3). ConvergentvalidityanddivergentvaliditywereassessedwithbaselinedatafromStudies1and2insubjectswithacuteagitation.To investigateconvergentvalidity,wesoughtPearsonandSpearmancorrelationofBARS TM scoreswithscoresontheClinicalGlobal Impression of Severity (CGI-S) Scale and a predefined cluster of agitation-related items from the Positive and Negative Syndrome Scale (PANSS). For divergent validity, we sought Pearson and Spearman correlation between BARS TM scores and a predefined cluster of PANSS items measuring negative symptoms. Discriminant validity was investigated with the help of subjects with mod- erate psychopathology (Study 3). Wilcoxon rank-sum and two-sample t tests determined whether mean (or median) BARS TM scoresdifferedbetweensubjectswithacuteagitation(Studies1and2)andmoderatepsychopathology(Study3).Responsivenessto treatment effect and rater reliability were also evaluated. In Study 2, Pearson correlation coefficients of BARS TM scores with PANSS agitation items and CGI-S were moderate (convergent validity) and statistically significant (P < 0.005). The correlation between BARS TM scores and PANSS negative component scores was low (divergent validity). Treatment effect size was larger for BARS TM than for PANSS agitation items and CGI-S (responsive to treatment differences). Virtually perfect inter- and intra-rater reliability was achieved. Study 1 produced similar results. BARS TM showed psychometrically valid properties for measurement of behavioral activity in acutely agitated patients with psychosis. # 2002ElsevierScienceLtd.Allrightsreserved. Keywords: Behavioural Activity Rating Scale; Psychometric validation; Ziprasidone 1. Introduction Several assessment scales, including the Brief Psy- chiatric Rating Scale (BPRS; Overall and Gorham, 1962), the Clinical Global Impression (CGI; National Institute of Mental Health, 1976), and the Positive and Negative Syndrome Scale for schizophrenia (PANSS; Kay et al., 1987), have been used to evaluate the psy- chopathology of schizophrenia and the long-term effi- cacyofantipsychotictreatment.TheBPRSandClinical Global Impression of Severity (CGI-S) Scale have been usedtocomparetheefficacyoflorazepamandhaloper- idol (Foster et al., 1997) and that of zuclopenthixol acetate and haloperidol (Brook et al., 1998) for the treatment of acutely agitated psychotic patients. All three scales (BPRS, CGI-S, and PANSS) have provided some information on improvements in psy- chopathology achieved with ziprasidone, a novel anti- psychoticagent,inclinicaltrials(Goffetal.,1998;Kecket al., 1998; Daniel et al., 1999). Intramuscular (IM) ziprasi- done has been found to reduce activity levels and to increasethedegreeof‘‘calm’’inpatientswithpsychosisand acute agitation, without causing profound sedation (Daniel et al., 2001; Lesem et al., 2001). None of these scales contains items that specifically and directly measurebehavioralactivityoverashorttime.Henceno tool exists to adequately measure the therapeutic effects ofIMziprasidoneandrelateddrugsinclinicaltrials. Other scales quantify aggression and agitation to varying degrees. Salzman et al. (1991) used the Overt Aggression Scale (OAS; Yudofsky et al., 1986) to com- pare treatments of psychotic disruptive behavior. Bat- taglia et al. (1997) used the Agitated Behavior Scale (ABS; Corrigan, 1989) to evaluate control of psychotic 0022-3956/02/$ - see front matter # 2002 Elsevier Science Ltd. All rights reserved. PII:S0022-3956(01)00052-8 Journal of Psychiatric Research 36 (2002) 87–95 www.elsevier.com/locate/jpsychires * Correspondingauthor.Tel.:+1-860-441-8668;fax:+1-860-441-8751. E-mail address: joseph_c_cappelleri@groton.pfizer.com (J.C. Cappelleri).