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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/lilly.com; Fangyi Zhao: ZHAO_FANGYI/at/LILLY.COM; Holland C Detke: detkehc/at/lilly.com; Allen W Nyhuis: NYHUIS_ALLEN/at/LILLY.COM; Anthony H Lawson: LAWSON_ANTHONY_HOWARD/at/LILLY.COM; Virginia L Stauffer: vstauffer/at/lilly.com; William Montgomery: montgomer_bill/at/lilly.com; Michael M Witte: WITTE_MICHAEL_M/at/LILLY.COM; David P McDonnell: mcdonnelldp/at/lilly.com
Received March 21, 2011; Accepted September 23, 2011.
Abstract
Background
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.
Methods
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.
Results
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.
Conclusions
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 http://clinicaltrials.gov/ct2/show/NCT00088478?term=olanzapine+depot&rank=3
Registry identifier - NCT00088478
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