Clozapine for the treatment of drug‐induced psychosis in Parkinson's disease: Results of the 12 week open label extension in the PSYCLOPS trial
Identifieur interne : 001A87 ( Main/Corpus ); précédent : 001A86; suivant : 001A88Clozapine for the treatment of drug‐induced psychosis in Parkinson's disease: Results of the 12 week open label extension in the PSYCLOPS trial
Auteurs : Stewart A. Factor ; Joseph H. Friedman ; Margaret C. Lannon ; David Oakes ; Keith BourgeoisSource :
- Movement Disorders [ 0885-3185 ] ; 2001-01.
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- KwdEn :
Abstract
OBJECTIVE: To report the results of the 12‐week, prospective, open label extension of the 4‐week, multicenter, placebo‐controlled, double‐blind PSYCLOPS (PSYchosis and CLOzapine in the treatment of Parkinsonism) trial. This extension examined the chronic safety and efficacy of clozapine in the treatment of drug‐induced psychosis in Parkinson's disease (PD). BACKGROUND: Psychosis is a serious late complication of PD and may be a harbinger to increased mortality. Clozapine, the first atypical antipsychotic, was shown in several small open label studies to improve psychosis without worsening of motor symptoms. This was recently confirmed in the double‐blind PSYCLOPS trial. METHODS: The 53 patients who completed the double‐blind portion of PSYCLOPS were evaluated on their original randomized treatment (clozapine or placebo), then had study medication stopped. All were started on clozapine. The patients from both treatment groups were evaluated every 4 weeks over a 12‐week period using standardized measures for psychosis and PD. RESULTS: The mean dose of clozapine was 28.78 mg/day. Those originally treated with placebo improved significantly in Brief Psychiatric Rating Scale and clinical global scores for psychosis to the same degree as the group originally randomized to clozapine in the double‐blind study. Both groups maintained their response to week 16 (end of the combined double‐blind and open label portions). There was no worsening of motor features as measured by the Unified Parkinson's disease rating scale. Eighteen patients were either hospitalized or died during the trial. The most common reasons were pulmonary. CONCLUSIONS: Low‐dose clozapine is effective in treating drug‐induced psychosis without worsening motor features of PD, and the response is maintained for at least 4 months. Patients with psychosis and PD were previously described as a group with high risk for morbidity and mortality. The high risk continues despite antipsychotic therapy. Mov. Disord. 16:135–139, 2001. © 2001 Movement Disorder Society.
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DOI: 10.1002/1531-8257(200101)16:1<135::AID-MDS1006>3.0.CO;2-Q
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This extension examined the chronic safety and efficacy of clozapine in the treatment of drug‐induced psychosis in Parkinson's disease (PD). BACKGROUND: Psychosis is a serious late complication of PD and may be a harbinger to increased mortality. Clozapine, the first atypical antipsychotic, was shown in several small open label studies to improve psychosis without worsening of motor symptoms. This was recently confirmed in the double‐blind PSYCLOPS trial. METHODS: The 53 patients who completed the double‐blind portion of PSYCLOPS were evaluated on their original randomized treatment (clozapine or placebo), then had study medication stopped. All were started on clozapine. The patients from both treatment groups were evaluated every 4 weeks over a 12‐week period using standardized measures for psychosis and PD. RESULTS: The mean dose of clozapine was 28.78 mg/day. Those originally treated with placebo improved significantly in Brief Psychiatric Rating Scale and clinical global scores for psychosis to the same degree as the group originally randomized to clozapine in the double‐blind study. Both groups maintained their response to week 16 (end of the combined double‐blind and open label portions). There was no worsening of motor features as measured by the Unified Parkinson's disease rating scale. Eighteen patients were either hospitalized or died during the trial. The most common reasons were pulmonary. CONCLUSIONS: Low‐dose clozapine is effective in treating drug‐induced psychosis without worsening motor features of PD, and the response is maintained for at least 4 months. Patients with psychosis and PD were previously described as a group with high risk for morbidity and mortality. The high risk continues despite antipsychotic therapy. Mov. Disord. 16:135–139, 2001. © 2001 Movement Disorder Society.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Stewart A. Factor DO</name><affiliations><json:string>Albany Medical College, Albany, New York, USA</json:string></affiliations></json:item><json:item><name>Joseph H. Friedman MD</name><affiliations><json:string>Memorial Hospital of Rhode Island, Pawtucket, Rhode Island, USA</json:string></affiliations></json:item><json:item><name>Margaret C. Lannon RN, MS</name><affiliations><json:string>Memorial Hospital of Rhode Island, Pawtucket, Rhode Island, USA</json:string></affiliations></json:item><json:item><name>David Oakes PhD</name><affiliations><json:string>University of Rochester, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Keith Bourgeois BS</name><affiliations><json:string>University of Rochester, Rochester, New York, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>psychosis</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>clozapine</value></json:item></subject><articleId><json:string>MDS1006</json:string></articleId><language><json:string>eng</json:string></language><abstract>OBJECTIVE: To report the results of the 12‐week, prospective, open label extension of the 4‐week, multicenter, placebo‐controlled, double‐blind PSYCLOPS (PSYchosis and CLOzapine in the treatment of Parkinsonism) trial. 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Those originally treated with placebo improved significantly in Brief Psychiatric Rating Scale and clinical global scores for psychosis to the same degree as the group originally randomized to clozapine in the double‐blind study. Both groups maintained their response to week 16 (end of the combined double‐blind and open label portions). There was no worsening of motor features as measured by the Unified Parkinson's disease rating scale. Eighteen patients were either hospitalized or died during the trial. The most common reasons were pulmonary. CONCLUSIONS: Low‐dose clozapine is effective in treating drug‐induced psychosis without worsening motor features of PD, and the response is maintained for at least 4 months. Patients with psychosis and PD were previously described as a group with high risk for morbidity and mortality. The high risk continues despite antipsychotic therapy. Mov. 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Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>John Wiley & Sons, Inc.</publisher><pubPlace>New York</pubPlace><date type="published" when="2001-01"></date><biblScope unit="volume">16</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="135">135</biblScope><biblScope unit="page" to="139">139</biblScope></imprint></monogr><idno type="istex">7C6A64F96D1F129F8EE5A485472A044FC7B6BC90</idno><idno type="DOI">10.1002/1531-8257(200101)16:1<135::AID-MDS1006>3.0.CO;2-Q</idno><idno type="ArticleID">MDS1006</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2001</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>OBJECTIVE: To report the results of the 12‐week, prospective, open label extension of the 4‐week, multicenter, placebo‐controlled, double‐blind PSYCLOPS (PSYchosis and CLOzapine in the treatment of Parkinsonism) trial. This extension examined the chronic safety and efficacy of clozapine in the treatment of drug‐induced psychosis in Parkinson's disease (PD). BACKGROUND: Psychosis is a serious late complication of PD and may be a harbinger to increased mortality. Clozapine, the first atypical antipsychotic, was shown in several small open label studies to improve psychosis without worsening of motor symptoms. This was recently confirmed in the double‐blind PSYCLOPS trial. METHODS: The 53 patients who completed the double‐blind portion of PSYCLOPS were evaluated on their original randomized treatment (clozapine or placebo), then had study medication stopped. All were started on clozapine. The patients from both treatment groups were evaluated every 4 weeks over a 12‐week period using standardized measures for psychosis and PD. RESULTS: The mean dose of clozapine was 28.78 mg/day. Those originally treated with placebo improved significantly in Brief Psychiatric Rating Scale and clinical global scores for psychosis to the same degree as the group originally randomized to clozapine in the double‐blind study. Both groups maintained their response to week 16 (end of the combined double‐blind and open label portions). There was no worsening of motor features as measured by the Unified Parkinson's disease rating scale. Eighteen patients were either hospitalized or died during the trial. The most common reasons were pulmonary. CONCLUSIONS: Low‐dose clozapine is effective in treating drug‐induced psychosis without worsening motor features of PD, and the response is maintained for at least 4 months. Patients with psychosis and PD were previously described as a group with high risk for morbidity and mortality. The high risk continues despite antipsychotic therapy. Mov. Disord. 16:135–139, 2001. © 2001 Movement Disorder Society.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Parkinson's disease</term></item><item><term>psychosis</term></item><item><term>clozapine</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>Brief Report</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2000-03-15">Received</change><change when="2000-07-20">Registration</change><change when="2001-01">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/7C6A64F96D1F129F8EE5A485472A044FC7B6BC90/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>John Wiley & Sons, Inc.</publisherName><publisherLoc>New York</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="subtitle">Official Journal of the Movement Disorder Society</title><title type="short">Mov. 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This extension examined the chronic safety and efficacy of clozapine in the treatment of drug‐induced psychosis in Parkinson's disease (PD).</p></section><section xml:id="abs1-2"><title type="main">BACKGROUND</title><p>Psychosis is a serious late complication of PD and may be a harbinger to increased mortality. Clozapine, the first atypical antipsychotic, was shown in several small open label studies to improve psychosis without worsening of motor symptoms. This was recently confirmed in the double‐blind PSYCLOPS trial.</p></section><section xml:id="abs1-3"><title type="main">METHODS</title><p>The 53 patients who completed the double‐blind portion of PSYCLOPS were evaluated on their original randomized treatment (clozapine or placebo), then had study medication stopped. All were started on clozapine. The patients from both treatment groups were evaluated every 4 weeks over a 12‐week period using standardized measures for psychosis and PD.</p></section><section xml:id="abs1-4"><title type="main">RESULTS</title><p>The mean dose of clozapine was 28.78 mg/day. Those originally treated with placebo improved significantly in Brief Psychiatric Rating Scale and clinical global scores for psychosis to the same degree as the group originally randomized to clozapine in the double‐blind study. Both groups maintained their response to week 16 (end of the combined double‐blind and open label portions). There was no worsening of motor features as measured by the Unified Parkinson's disease rating scale. Eighteen patients were either hospitalized or died during the trial. The most common reasons were pulmonary.</p></section><section xml:id="abs1-5"><title type="main">CONCLUSIONS</title><p>Low‐dose clozapine is effective in treating drug‐induced psychosis without worsening motor features of PD, and the response is maintained for at least 4 months. Patients with psychosis and PD were previously described as a group with high risk for morbidity and mortality. The high risk continues despite antipsychotic therapy. Mov. Disord. 16:135–139, 2001. © 2001 Movement Disorder Society.</p></section></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Clozapine for the treatment of drug‐induced psychosis in Parkinson's disease: Results of the 12 week open label extension in the PSYCLOPS trial</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Clozapine Therapy for Psychosis in PD</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Clozapine for the treatment of drug‐induced psychosis in Parkinson's disease: Results of the 12 week open label extension in the PSYCLOPS trial</title></titleInfo><name type="personal"><namePart type="given">Stewart A.</namePart><namePart type="family">Factor</namePart><namePart type="termsOfAddress">DO</namePart><affiliation>Albany Medical College, Albany, New York, USA</affiliation><description>Correspondence: Parkinson's Disease and Movement Disorder Center of Albany Medical Center, 215 Washington Ave. Ext., Albany, NY 12203</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Joseph H.</namePart><namePart type="family">Friedman</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Memorial Hospital of Rhode Island, Pawtucket, Rhode Island, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Margaret C.</namePart><namePart type="family">Lannon</namePart><namePart type="termsOfAddress">RN, MS</namePart><affiliation>Memorial Hospital of Rhode Island, Pawtucket, Rhode Island, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">David</namePart><namePart type="family">Oakes</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>University of Rochester, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Keith</namePart><namePart type="family">Bourgeois</namePart><namePart type="termsOfAddress">BS</namePart><affiliation>University of Rochester, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="brief communication" displayLabel="shortCommunication"></genre><originInfo><publisher>John Wiley & Sons, Inc.</publisher><place><placeTerm type="text">New York</placeTerm></place><dateIssued encoding="w3cdtf">2001-01</dateIssued><dateCaptured encoding="w3cdtf">2000-03-15</dateCaptured><dateValid encoding="w3cdtf">2000-07-20</dateValid><copyrightDate encoding="w3cdtf">2001</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="tables">2</extent><extent unit="references">24</extent><extent unit="words">2868</extent></physicalDescription><abstract lang="en">OBJECTIVE: To report the results of the 12‐week, prospective, open label extension of the 4‐week, multicenter, placebo‐controlled, double‐blind PSYCLOPS (PSYchosis and CLOzapine in the treatment of Parkinsonism) trial. This extension examined the chronic safety and efficacy of clozapine in the treatment of drug‐induced psychosis in Parkinson's disease (PD). BACKGROUND: Psychosis is a serious late complication of PD and may be a harbinger to increased mortality. Clozapine, the first atypical antipsychotic, was shown in several small open label studies to improve psychosis without worsening of motor symptoms. This was recently confirmed in the double‐blind PSYCLOPS trial. METHODS: The 53 patients who completed the double‐blind portion of PSYCLOPS were evaluated on their original randomized treatment (clozapine or placebo), then had study medication stopped. All were started on clozapine. The patients from both treatment groups were evaluated every 4 weeks over a 12‐week period using standardized measures for psychosis and PD. RESULTS: The mean dose of clozapine was 28.78 mg/day. Those originally treated with placebo improved significantly in Brief Psychiatric Rating Scale and clinical global scores for psychosis to the same degree as the group originally randomized to clozapine in the double‐blind study. Both groups maintained their response to week 16 (end of the combined double‐blind and open label portions). There was no worsening of motor features as measured by the Unified Parkinson's disease rating scale. Eighteen patients were either hospitalized or died during the trial. The most common reasons were pulmonary. CONCLUSIONS: Low‐dose clozapine is effective in treating drug‐induced psychosis without worsening motor features of PD, and the response is maintained for at least 4 months. Patients with psychosis and PD were previously described as a group with high risk for morbidity and mortality. The high risk continues despite antipsychotic therapy. Mov. Disord. 16:135–139, 2001. © 2001 Movement Disorder Society.</abstract><note type="funding">Orphan Drug Division of the FDA - No. FD‐R‐001416‐02; </note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>psychosis</topic><topic>clozapine</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><subject><genre>article category</genre><topic>Brief Report</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2001</date><detail type="volume"><caption>vol.</caption><number>16</number></detail><detail type="issue"><caption>no.</caption><number>1</number></detail><extent unit="pages"><start>135</start><end>139</end><total>5</total></extent></part></relatedItem><identifier type="istex">7C6A64F96D1F129F8EE5A485472A044FC7B6BC90</identifier><identifier type="DOI">10.1002/1531-8257(200101)16:1<135::AID-MDS1006>3.0.CO;2-Q</identifier><identifier type="ArticleID">MDS1006</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2001 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>John Wiley & Sons, Inc.</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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