TY - JOUR
T1 - Interpreting treatment trials in schizophrenia patients
T2 - Lessons learned from EUFEST
AU - Fleischhacker, W. Wolfgang
AU - Derks, Eske
AU - Kahn, Rene S.
PY - 2012/6
Y1 - 2012/6
N2 - There are various procedures to account for missing values in clinical trials. Mixed Model and Last Observation Carried Forward (LOCF) analyses are commonly employed methods. We compared the two methods by reanalysing Positive and Negative Syndrome Scale (PANSS) scores from the European First Episode in Schizophrenia Trial (EUFEST). While the predefined Mixed Model analysis detected no differences between PANSS total score changes in first episode patients treated with haloperidol, amisulpride, quetiapine, olanzapine or ziprasidone over the course of a one year treatment trial, a LOCF analysis revealed significant differences in favor of the new generation antipsychotics over haloperidol. Implications for clinical trial design and the interpretation of such studies are discussed.
AB - There are various procedures to account for missing values in clinical trials. Mixed Model and Last Observation Carried Forward (LOCF) analyses are commonly employed methods. We compared the two methods by reanalysing Positive and Negative Syndrome Scale (PANSS) scores from the European First Episode in Schizophrenia Trial (EUFEST). While the predefined Mixed Model analysis detected no differences between PANSS total score changes in first episode patients treated with haloperidol, amisulpride, quetiapine, olanzapine or ziprasidone over the course of a one year treatment trial, a LOCF analysis revealed significant differences in favor of the new generation antipsychotics over haloperidol. Implications for clinical trial design and the interpretation of such studies are discussed.
UR - http://www.scopus.com/inward/record.url?scp=84861529349&partnerID=8YFLogxK
U2 - 10.1016/j.schres.2012.03.027
DO - 10.1016/j.schres.2012.03.027
M3 - Article
C2 - 22542244
AN - SCOPUS:84861529349
SN - 0920-9964
VL - 138
SP - 39
EP - 40
JO - Schizophrenia Research
JF - Schizophrenia Research
IS - 1
ER -