Different safety profiles of risperidone and paliperidone extended-release: a double-blind, placebo-controlled trial with healthy volunteers
Objective The present study investigated subjective experiences related to secondary negative symptoms and cognitive performance in healthy volunteers in response to the repeated administration of paliperidone extended‐release (ER) and risperidone in a double‐blind, placebo‐controlled trial. Methods...
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| Veröffentlicht in: | Human psychopharmacology 2012-05, Vol.27 (3), p.305-314 |
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| creator | Yoon, Kil-Sang Park, Tae-Won Yang, Jong-Chul Kim, Min-Gul Oh, Keun-Young Park, Myung-Sook Chung, Young-Chul |
| description | Objective
The present study investigated subjective experiences related to secondary negative symptoms and cognitive performance in healthy volunteers in response to the repeated administration of paliperidone extended‐release (ER) and risperidone in a double‐blind, placebo‐controlled trial.
Methods
Participants (n = 32) received a fixed dose of one of three study medications for three consecutive days: 6 mg of paliperidone ER, 3 mg of risperidone, or placebo. Subjects were evaluated at baseline and after the first and third administrations of the medications by using the Neuroleptic‐Induced Deficit Syndrome Scale and the Scale for the Assessment of Negative Symptoms. Cognitive function was measured at baseline and after the third administration of the medications by using the computerized neuropsychological test.
Results
Risperidone was associated with more detrimental subjective experiences compared with paliperidone ER and placebo (p |
| doi_str_mv | 10.1002/hup.2227 |
| format | Article |
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The present study investigated subjective experiences related to secondary negative symptoms and cognitive performance in healthy volunteers in response to the repeated administration of paliperidone extended‐release (ER) and risperidone in a double‐blind, placebo‐controlled trial.
Methods
Participants (n = 32) received a fixed dose of one of three study medications for three consecutive days: 6 mg of paliperidone ER, 3 mg of risperidone, or placebo. Subjects were evaluated at baseline and after the first and third administrations of the medications by using the Neuroleptic‐Induced Deficit Syndrome Scale and the Scale for the Assessment of Negative Symptoms. Cognitive function was measured at baseline and after the third administration of the medications by using the computerized neuropsychological test.
Results
Risperidone was associated with more detrimental subjective experiences compared with paliperidone ER and placebo (p < .05), and these differences persisted after controlling for mental and physical sedation. Analysis of computerized neuropsychological test variables revealed significant differences in the changes in Stroop word–color test results from baseline between the paliperidone ER and risperidone groups (p < .005) and between the placebo and risperidone groups (p < .005).
Conclusions
These results suggest that paliperidone ER may have a better safety profile than risperidone in terms of negative subjective experiences and cognitive function among normal volunteers. Copyright © 2012 John Wiley & Sons, Ltd.</description><identifier>ISSN: 0885-6222</identifier><identifier>EISSN: 1099-1077</identifier><identifier>DOI: 10.1002/hup.2227</identifier><identifier>PMID: 22585590</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Ltd</publisher><subject>Adult ; Analysis of Variance ; Antipsychotic Agents - administration & dosage ; Chi-Square Distribution ; Cognition - drug effects ; cognitive function ; Double-Blind Method ; Drug Administration Schedule ; Drug Delivery Systems ; Female ; Humans ; Isoxazoles - administration & dosage ; Male ; negative symptoms ; Neuropsychological Tests ; Pain Measurement ; paliperidone ; Paliperidone Palmitate ; Psychiatric Status Rating Scales ; Pyrimidines - administration & dosage ; Risperidone - administration & dosage ; schizophrenia ; Substance-Related Disorders - diagnosis ; Substance-Related Disorders - etiology ; Time Factors</subject><ispartof>Human psychopharmacology, 2012-05, Vol.27 (3), p.305-314</ispartof><rights>Copyright © 2012 John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3597-c352a4dbdd0f20f549062b1e734daab42d31967a9030af0fb057d8701765babb3</citedby><cites>FETCH-LOGICAL-c3597-c352a4dbdd0f20f549062b1e734daab42d31967a9030af0fb057d8701765babb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fhup.2227$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fhup.2227$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22585590$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yoon, Kil-Sang</creatorcontrib><creatorcontrib>Park, Tae-Won</creatorcontrib><creatorcontrib>Yang, Jong-Chul</creatorcontrib><creatorcontrib>Kim, Min-Gul</creatorcontrib><creatorcontrib>Oh, Keun-Young</creatorcontrib><creatorcontrib>Park, Myung-Sook</creatorcontrib><creatorcontrib>Chung, Young-Chul</creatorcontrib><title>Different safety profiles of risperidone and paliperidone extended-release: a double-blind, placebo-controlled trial with healthy volunteers</title><title>Human psychopharmacology</title><addtitle>Hum. Psychopharmacol Clin Exp</addtitle><description>Objective
The present study investigated subjective experiences related to secondary negative symptoms and cognitive performance in healthy volunteers in response to the repeated administration of paliperidone extended‐release (ER) and risperidone in a double‐blind, placebo‐controlled trial.
Methods
Participants (n = 32) received a fixed dose of one of three study medications for three consecutive days: 6 mg of paliperidone ER, 3 mg of risperidone, or placebo. Subjects were evaluated at baseline and after the first and third administrations of the medications by using the Neuroleptic‐Induced Deficit Syndrome Scale and the Scale for the Assessment of Negative Symptoms. Cognitive function was measured at baseline and after the third administration of the medications by using the computerized neuropsychological test.
Results
Risperidone was associated with more detrimental subjective experiences compared with paliperidone ER and placebo (p < .05), and these differences persisted after controlling for mental and physical sedation. Analysis of computerized neuropsychological test variables revealed significant differences in the changes in Stroop word–color test results from baseline between the paliperidone ER and risperidone groups (p < .005) and between the placebo and risperidone groups (p < .005).
Conclusions
These results suggest that paliperidone ER may have a better safety profile than risperidone in terms of negative subjective experiences and cognitive function among normal volunteers. Copyright © 2012 John Wiley & Sons, Ltd.</description><subject>Adult</subject><subject>Analysis of Variance</subject><subject>Antipsychotic Agents - administration & dosage</subject><subject>Chi-Square Distribution</subject><subject>Cognition - drug effects</subject><subject>cognitive function</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug Delivery Systems</subject><subject>Female</subject><subject>Humans</subject><subject>Isoxazoles - administration & dosage</subject><subject>Male</subject><subject>negative symptoms</subject><subject>Neuropsychological Tests</subject><subject>Pain Measurement</subject><subject>paliperidone</subject><subject>Paliperidone Palmitate</subject><subject>Psychiatric Status Rating Scales</subject><subject>Pyrimidines - administration & dosage</subject><subject>Risperidone - administration & dosage</subject><subject>schizophrenia</subject><subject>Substance-Related Disorders - diagnosis</subject><subject>Substance-Related Disorders - etiology</subject><subject>Time Factors</subject><issn>0885-6222</issn><issn>1099-1077</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kMFuEzEQhi0EommpxBMgHzmwZWxn11luqNAWEUEPLeVm2euxYnDWW9tLm3fgodmoaTj1MiPN_-mX5iPkNYMTBsDfr8bhhHMun5EZg7atGEj5nMxgsairZgoOyGHOvwCmDNqX5IDzelHXLczI30_eOUzYF5q1w7KhQ4rOB8w0Opp8HjB5G3ukurd00MHvD3hfsLdoq4QBdcYPVFMbRxOwMsH39h0dgu7QxKqLfUkxBLS0JK8DvfNlRVeoQ1lt6J8Yxr4gpvyKvHA6ZDze7SNyffb56vSiWn4__3L6cVl1om7ldnI9t8ZacBxcPW-h4YahFHOrtZlzK1jbSN2CAO3AGailXUhgsqmNNkYckbcPvdOvtyPmotY-dxiC7jGOWTFgouUMuPiPdinmnNCpIfm1TpsJUlv3anKvtu4n9M2udTRrtHvwUfYEVA_A3eR382SRuri-3BXueJ8L3u95nX6rRgpZq5tv5-rr1VL8-Hm5VI34BwXOn-U</recordid><startdate>201205</startdate><enddate>201205</enddate><creator>Yoon, Kil-Sang</creator><creator>Park, Tae-Won</creator><creator>Yang, Jong-Chul</creator><creator>Kim, Min-Gul</creator><creator>Oh, Keun-Young</creator><creator>Park, Myung-Sook</creator><creator>Chung, Young-Chul</creator><general>John Wiley & Sons, Ltd</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>201205</creationdate><title>Different safety profiles of risperidone and paliperidone extended-release: a double-blind, placebo-controlled trial with healthy volunteers</title><author>Yoon, Kil-Sang ; Park, Tae-Won ; Yang, Jong-Chul ; Kim, Min-Gul ; Oh, Keun-Young ; Park, Myung-Sook ; Chung, Young-Chul</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3597-c352a4dbdd0f20f549062b1e734daab42d31967a9030af0fb057d8701765babb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Analysis of Variance</topic><topic>Antipsychotic Agents - administration & dosage</topic><topic>Chi-Square Distribution</topic><topic>Cognition - drug effects</topic><topic>cognitive function</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Drug Delivery Systems</topic><topic>Female</topic><topic>Humans</topic><topic>Isoxazoles - administration & dosage</topic><topic>Male</topic><topic>negative symptoms</topic><topic>Neuropsychological Tests</topic><topic>Pain Measurement</topic><topic>paliperidone</topic><topic>Paliperidone Palmitate</topic><topic>Psychiatric Status Rating Scales</topic><topic>Pyrimidines - administration & dosage</topic><topic>Risperidone - administration & dosage</topic><topic>schizophrenia</topic><topic>Substance-Related Disorders - diagnosis</topic><topic>Substance-Related Disorders - etiology</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yoon, Kil-Sang</creatorcontrib><creatorcontrib>Park, Tae-Won</creatorcontrib><creatorcontrib>Yang, Jong-Chul</creatorcontrib><creatorcontrib>Kim, Min-Gul</creatorcontrib><creatorcontrib>Oh, Keun-Young</creatorcontrib><creatorcontrib>Park, Myung-Sook</creatorcontrib><creatorcontrib>Chung, Young-Chul</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Human psychopharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yoon, Kil-Sang</au><au>Park, Tae-Won</au><au>Yang, Jong-Chul</au><au>Kim, Min-Gul</au><au>Oh, Keun-Young</au><au>Park, Myung-Sook</au><au>Chung, Young-Chul</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Different safety profiles of risperidone and paliperidone extended-release: a double-blind, placebo-controlled trial with healthy volunteers</atitle><jtitle>Human psychopharmacology</jtitle><addtitle>Hum. Psychopharmacol Clin Exp</addtitle><date>2012-05</date><risdate>2012</risdate><volume>27</volume><issue>3</issue><spage>305</spage><epage>314</epage><pages>305-314</pages><issn>0885-6222</issn><eissn>1099-1077</eissn><abstract>Objective
The present study investigated subjective experiences related to secondary negative symptoms and cognitive performance in healthy volunteers in response to the repeated administration of paliperidone extended‐release (ER) and risperidone in a double‐blind, placebo‐controlled trial.
Methods
Participants (n = 32) received a fixed dose of one of three study medications for three consecutive days: 6 mg of paliperidone ER, 3 mg of risperidone, or placebo. Subjects were evaluated at baseline and after the first and third administrations of the medications by using the Neuroleptic‐Induced Deficit Syndrome Scale and the Scale for the Assessment of Negative Symptoms. Cognitive function was measured at baseline and after the third administration of the medications by using the computerized neuropsychological test.
Results
Risperidone was associated with more detrimental subjective experiences compared with paliperidone ER and placebo (p < .05), and these differences persisted after controlling for mental and physical sedation. Analysis of computerized neuropsychological test variables revealed significant differences in the changes in Stroop word–color test results from baseline between the paliperidone ER and risperidone groups (p < .005) and between the placebo and risperidone groups (p < .005).
Conclusions
These results suggest that paliperidone ER may have a better safety profile than risperidone in terms of negative subjective experiences and cognitive function among normal volunteers. Copyright © 2012 John Wiley & Sons, Ltd.</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>22585590</pmid><doi>10.1002/hup.2227</doi><tpages>10</tpages></addata></record> |
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| subjects | Adult Analysis of Variance Antipsychotic Agents - administration & dosage Chi-Square Distribution Cognition - drug effects cognitive function Double-Blind Method Drug Administration Schedule Drug Delivery Systems Female Humans Isoxazoles - administration & dosage Male negative symptoms Neuropsychological Tests Pain Measurement paliperidone Paliperidone Palmitate Psychiatric Status Rating Scales Pyrimidines - administration & dosage Risperidone - administration & dosage schizophrenia Substance-Related Disorders - diagnosis Substance-Related Disorders - etiology Time Factors |
| title | Different safety profiles of risperidone and paliperidone extended-release: a double-blind, placebo-controlled trial with healthy volunteers |
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