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Logo of bmcpsycBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Psychiatry
BMC Psychiatry. 2011; 11: 152.
Published online Sep 23, 2011. doi:  10.1186/1471-244X-11-152
PMCID: PMC3187740
Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia
Haya Ascher-Svanum,corresponding author1 Fangyi Zhao,2 Holland C Detke,2 Allen W Nyhuis,3 Anthony H Lawson,1 Virginia L Stauffer,2 William Montgomery,4 Michael M Witte,3 and David P McDonnell5
1Global Health Outcomes, Eli Lilly and Company; Lilly Corporate Center, DC 4133; Indianapolis, IN, 46285 USA
2Psychosis Team, Eli Lilly and Company; Lilly Corporate Center, DC 6156; Indianapolis, IN 46285 USA
3Lilly Neuroscience, Lilly USA LLC; Indianapolis, IN, USA
4Eli Lilly Australia Pty Ltd; West Ryde, NSW, Australia
5Eli Lilly and Company; Cork ELCL, UK
corresponding authorCorresponding author.
Haya Ascher-Svanum: haya/at/; Fangyi Zhao: ZHAO_FANGYI/at/LILLY.COM; Holland C Detke: detkehc/at/; Allen W Nyhuis: NYHUIS_ALLEN/at/LILLY.COM; Anthony H Lawson: LAWSON_ANTHONY_HOWARD/at/LILLY.COM; Virginia L Stauffer: vstauffer/at/; William Montgomery: montgomer_bill/at/; Michael M Witte: WITTE_MICHAEL_M/at/LILLY.COM; David P McDonnell: mcdonnelldp/at/
Received March 21, 2011; Accepted September 23, 2011.
In patients with schizophrenia, early non-response to oral antipsychotic therapy robustly predicts subsequent non-response to continued treatment with the same medication. This study assessed whether early response predicted later response when using a long-acting injection (LAI) antipsychotic.
Data were taken from an 8-week, randomized, double-blind, placebo-controlled study of olanzapine LAI in acutely ill patients with schizophrenia (n = 233). Early response was defined as ≥30% improvement from baseline to Week 4 in Positive and Negative Syndrome Scale (PANSS0-6) Total score. Subsequent response was defined as ≥40% baseline-to-endpoint improvement in PANSS0-6 Total score. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and predictive accuracy were calculated. Clinical and functional outcomes were compared between Early Responders and Early Non-responders.
Early response/non-response to olanzapine LAI predicted later response/non-response with high sensitivity (85%), specificity (72%), PPV (78%), NPV (80%), and overall accuracy (79%). Compared to Early Non-responders, Early Responders had significantly greater improvement in PANSS0-6 Total scores at all time points and greater baseline-to-endpoint improvement in PANSS subscale scores, Quality of Life Scale scores, and Short Form-36 Health Survey scores (all p ≤ .01). Among Early Non-responders, 20% demonstrated response by Week 8. Patients who lacked early improvement (at Week 4) in Negative Symptoms and Disorganized Thoughts were more likely to continue being non-responders at Week 8.
Among acutely ill patients with schizophrenia, early response predicted subsequent response to olanzapine LAI. Early Responders experienced significantly better clinical and functional outcomes than Early Non-responders. Findings are consistent with previous research on oral antipsychotics.
Clinical Trials Registry
F1D-MC-HGJZ: Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia
Registry identifier - NCT00088478
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