title: Reliability, validity and ability to detect change of the PANSS negative symptom factor score in outpatients with schizophrenia on select antipsychotics and with prominent negative or disorganized thought symptoms.
abstract: The PANSS is a valid instrument assessing schizophrenia symptom severity. Analyses have identified a five-factor solution. The negative symptom factor (NSFS) is robust, having been replicated in multiple analyses. The score has superior content validity versus the negative subscale. Aspects of validity in patients with predominant negative symptoms have yet to be established. The present data are from a Phase IIb study of add-on bitopertin therapy in schizophrenia outpatients with prominent negative or disorganized thought symptoms treated with antipsychotics. Analyses were conducted to evaluate reliability, validity and sensitivity to change. Test-retest screening to baseline was high (ICC=0.93). This was maintained in-study, for patients with no change in CGI negative symptom severity (CGI-S-N). Internal consistency at baseline was adequate (α=0.71) and increased at later assessments. Pearson correlation at baseline showed a good association between NSFS and CGI-S-N (0.63), but not overall CGI-S (0.31). Association with PSP at baseline was moderate (-0.39) and for change at Week eight good (-0.65). NSFS responders (≥20% improvement) at Week eight showed a significant improvement in function. The analyses demonstrated reliability, validity and ability to detect change of the NSFS, in schizophrenia patients with prominent negative or disorganized thought symptoms.
authors.affiliation: Roche Products Ltd., 6 Falcon Way, Shire Park, Welwyn Garden City AL7 1TW, United Kingdom. Electronic address: chris.edgar@roche.com.
authors.forename: Chris J
authors.initials: CJ
authors.lastname: Edgar
authors.affiliation: F. Hoffmann-La Roche Ltd., Basel, Switzerland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Blaettler
authors.affiliation: F. Hoffmann-La Roche Ltd., Basel, Switzerland.
authors.forename: Dragana
authors.initials: D
authors.lastname: Bugarski-Kirola
authors.affiliation: Roche Products Ltd., 6 Falcon Way, Shire Park, Welwyn Garden City AL7 1TW, United Kingdom.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Le Scouiller
authors.affiliation: F. Hoffmann-La Roche Ltd., Basel, Switzerland.
authors.forename: George M
authors.initials: GM
authors.lastname: Garibaldi
authors.affiliation: Semel Institute for Neuroscience at UCLA and VA Desert Pacific Mental Illness Research, Education, and Clinical Center, Los Angeles, CA, USA.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Marder
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D010879:Piperazines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D015203:Reproducibility of Results; D012559:Schizophrenia / Q000175:diagnosis* / Q000188:drug therapy; D013450:Sulfones / Q000627:therapeutic use*; D063189:Symptom Assessment; D016896:Treatment Outcome
chemical_list: C550631:(4-(3-fluoro-5-trifluoromethylpyridin-2-yl)piperazin-1-yl)(5-methanesulfonyl-2-(2,2,2-trifluoro-1-methylethoxy)phenyl)methanone; D014150:Antipsychotic Agents; D010879:Piperazines; D013450:Sulfones
keywords: Clinical trials; NSFS; Negative symptom factor; Negative symptoms; Outcome assessment; PANSS; Psychiatric rating scales