Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia

<p>Abstract</p> <p>Background</p> <p>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 re...

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Main Authors: Stauffer Virginia L, Lawson Anthony H, Nyhuis Allen W, Detke Holland C, Zhao Fangyi, Ascher-Svanum Haya, Montgomery William, Witte Michael M, McDonnell David P
Format: Article
Language:English
Published: BMC 2011-09-01
Series:BMC Psychiatry
Online Access:http://www.biomedcentral.com/1471-244X/11/152
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author Stauffer Virginia L
Lawson Anthony H
Nyhuis Allen W
Detke Holland C
Zhao Fangyi
Ascher-Svanum Haya
Montgomery William
Witte Michael M
McDonnell David P
author_facet Stauffer Virginia L
Lawson Anthony H
Nyhuis Allen W
Detke Holland C
Zhao Fangyi
Ascher-Svanum Haya
Montgomery William
Witte Michael M
McDonnell David P
author_sort Stauffer Virginia L
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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 (PANSS<sub>0-6</sub>) Total score. Subsequent response was defined as ≥40% baseline-to-endpoint improvement in PANSS<sub>0-6 </sub>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.</p> <p>Results</p> <p>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 PANSS<sub>0-6 </sub>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.</p> <p>Conclusions</p> <p>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.</p> <p>Clinical Trials Registry</p> <p>F1D-MC-HGJZ: Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia <url>http://clinicaltrials.gov/ct2/show/NCT00088478?term=olanzapine+depot&rank=3</url></p> <p>Registry identifier - <a href="http://www.clinicaltrials.gov/ct2/show/NCT00088478">NCT00088478</a></p>
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spelling doaj.art-eec9369f779f40db9374ae3618719a382022-12-22T02:50:11ZengBMCBMC Psychiatry1471-244X2011-09-0111115210.1186/1471-244X-11-152Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophreniaStauffer Virginia LLawson Anthony HNyhuis Allen WDetke Holland CZhao FangyiAscher-Svanum HayaMontgomery WilliamWitte Michael MMcDonnell David P<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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 (PANSS<sub>0-6</sub>) Total score. Subsequent response was defined as ≥40% baseline-to-endpoint improvement in PANSS<sub>0-6 </sub>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.</p> <p>Results</p> <p>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 PANSS<sub>0-6 </sub>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.</p> <p>Conclusions</p> <p>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.</p> <p>Clinical Trials Registry</p> <p>F1D-MC-HGJZ: Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia <url>http://clinicaltrials.gov/ct2/show/NCT00088478?term=olanzapine+depot&rank=3</url></p> <p>Registry identifier - <a href="http://www.clinicaltrials.gov/ct2/show/NCT00088478">NCT00088478</a></p>http://www.biomedcentral.com/1471-244X/11/152
spellingShingle Stauffer Virginia L
Lawson Anthony H
Nyhuis Allen W
Detke Holland C
Zhao Fangyi
Ascher-Svanum Haya
Montgomery William
Witte Michael M
McDonnell David P
Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia
BMC Psychiatry
title Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia
title_full Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia
title_fullStr Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia
title_full_unstemmed Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia
title_short Early response predicts subsequent response to olanzapine long-acting injection in a randomized, double-blind clinical trial of treatment for schizophrenia
title_sort early response predicts subsequent response to olanzapine long acting injection in a randomized double blind clinical trial of treatment for schizophrenia
url http://www.biomedcentral.com/1471-244X/11/152
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