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...
Main Authors: | , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2011-09-01
|
Series: | BMC Psychiatry |
Online Access: | http://www.biomedcentral.com/1471-244X/11/152 |
_version_ | 1811312144602365952 |
---|---|
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> |
first_indexed | 2024-04-13T10:31:05Z |
format | Article |
id | doaj.art-eec9369f779f40db9374ae3618719a38 |
institution | Directory Open Access Journal |
issn | 1471-244X |
language | English |
last_indexed | 2024-04-13T10:31:05Z |
publishDate | 2011-09-01 |
publisher | BMC |
record_format | Article |
series | BMC Psychiatry |
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 |
work_keys_str_mv | AT stauffervirginial earlyresponsepredictssubsequentresponsetoolanzapinelongactinginjectioninarandomizeddoubleblindclinicaltrialoftreatmentforschizophrenia AT lawsonanthonyh earlyresponsepredictssubsequentresponsetoolanzapinelongactinginjectioninarandomizeddoubleblindclinicaltrialoftreatmentforschizophrenia AT nyhuisallenw earlyresponsepredictssubsequentresponsetoolanzapinelongactinginjectioninarandomizeddoubleblindclinicaltrialoftreatmentforschizophrenia AT detkehollandc earlyresponsepredictssubsequentresponsetoolanzapinelongactinginjectioninarandomizeddoubleblindclinicaltrialoftreatmentforschizophrenia AT zhaofangyi earlyresponsepredictssubsequentresponsetoolanzapinelongactinginjectioninarandomizeddoubleblindclinicaltrialoftreatmentforschizophrenia AT aschersvanumhaya earlyresponsepredictssubsequentresponsetoolanzapinelongactinginjectioninarandomizeddoubleblindclinicaltrialoftreatmentforschizophrenia AT montgomerywilliam earlyresponsepredictssubsequentresponsetoolanzapinelongactinginjectioninarandomizeddoubleblindclinicaltrialoftreatmentforschizophrenia AT wittemichaelm earlyresponsepredictssubsequentresponsetoolanzapinelongactinginjectioninarandomizeddoubleblindclinicaltrialoftreatmentforschizophrenia AT mcdonnelldavidp earlyresponsepredictssubsequentresponsetoolanzapinelongactinginjectioninarandomizeddoubleblindclinicaltrialoftreatmentforschizophrenia |