Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up
Identifieur interne : 001123 ( Main/Corpus ); précédent : 001122; suivant : 001124Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up
Auteurs : P. Pollak ; F. Tison ; O. Rascol ; A. Destée ; J J Péré ; J M Senard ; F. Durif ; I. BourdeixSource :
- Journal of Neurology, Neurosurgery & Psychiatry [ 0022-3050 ] ; 2004-05.
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- KwdEn :
Abstract
Objective: To compare the efficacy and safety of clozapine in drug induced psychosis in Parkinson’s disease (PD). Methods: A four week, randomised, double blind, parallel comparison of clozapine and placebo, followed by a 12 week clozapine open period, plus a one month period after drug discontinuation, in 60 patients with PD. The primary efficacy outcome was the “clinical global impression scale” (CGI); the positive subscore of the “positive and negative syndrome scale” (PANSS) was used as the secondary efficacy parameter and the “unified Parkinson’s disease rating scale” (UPDRS) and the “mini mental test examination” (MMSE) as safety outcomes. Results: The mean (SD) dosage of clozapine was 35.8 (12.5–50) mg at the end of the double blind period. The mean (SD) scores on the CGI improved by 1.8 (1.5) for the clozapine group compared with 0.6 (1.1) for the placebo group (p = 0.001). The mean (SD) positive subscore of PANSS improved by 5.6 (3.9) for the clozapine group (0.8 (2.8) for the placebo group; p < 0.0001). At the end of the open period, 25 patients had completely recovered from delusions and hallucinations, and 19 experienced a relapse within one month after the clozapine washout period. The UPDRS motor and MMSE mean scores did not change significantly in either group. Somnolence was more frequent with clozapine than with placebo. Conclusions: Clozapine at a mean dose lower than 50 mg/day improves drug induced psychosis in PD without significant worsening of motor function, and the effect wears off once the treatment stops.
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DOI: 10.1136/jnnp.2003.029868
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Pollak</name><affiliation><mods:affiliation>Department of Neurology, University Hospital of Grenoble, 38043 Grenoble Cedex 9, France</mods:affiliation></affiliation></author><author><name sortKey="Tison, F" sort="Tison, F" uniqKey="Tison F" first="F" last="Tison">F. Tison</name><affiliation><mods:affiliation>Fédération de Neurologie, University Hospital of Bordeaux, 33604 Pessac, France</mods:affiliation></affiliation></author><author><name sortKey="Rascol, O" sort="Rascol, O" uniqKey="Rascol O" first="O" last="Rascol">O. Rascol</name><affiliation><mods:affiliation>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U455, CHU Purpan, 31073 Toulouse University Hospital, France</mods:affiliation></affiliation></author><author><name sortKey="Destee, A" sort="Destee, A" uniqKey="Destee A" first="A" last="Destée">A. Destée</name><affiliation><mods:affiliation>Neurology and Movement Disorders Unit, Neurologie A, Hôpital Salengro, 59037 Lille, France</mods:affiliation></affiliation></author><author><name sortKey="Pere, J J" sort="Pere, J J" uniqKey="Pere J" first="J J" last="Péré">J J Péré</name><affiliation><mods:affiliation>Novartis Pharma, 92506 Rueil-Malmaison, France</mods:affiliation></affiliation></author><author><name sortKey="Senard, J M" sort="Senard, J M" uniqKey="Senard J" first="J M" last="Senard">J M Senard</name><affiliation><mods:affiliation>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U455, CHU Purpan, 31073 Toulouse University Hospital, France</mods:affiliation></affiliation></author><author><name sortKey="Durif, F" sort="Durif, F" uniqKey="Durif F" first="F" last="Durif">F. Durif</name><affiliation><mods:affiliation>Fédération de Neurologie, Hôpital Gabriel Montpied, 63033 Clermont-Ferrand Cedex I, France</mods:affiliation></affiliation></author><author><name sortKey="Bourdeix, I" sort="Bourdeix, I" uniqKey="Bourdeix I" first="I" last="Bourdeix">I. Bourdeix</name><affiliation><mods:affiliation>Novartis Pharma, 92506 Rueil-Malmaison, France</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Journal of Neurology, Neurosurgery & Psychiatry</title><title level="j" type="abbrev">J Neurol Neurosurg Psychiatry</title><idno type="ISSN">0022-3050</idno><idno type="eISSN">1468-330X</idno><imprint><publisher>BMJ Publishing Group Ltd</publisher><date type="published" when="2004-05">2004-05</date><biblScope unit="volume">75</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="689">689</biblScope></imprint><idno type="ISSN">0022-3050</idno></series><idno type="istex">D8CE96F619CD308F9DD33D29A5CCFC4FF3A19292</idno><idno type="DOI">10.1136/jnnp.2003.029868</idno><idno type="href">jnnp-75-689.pdf</idno><idno type="PMID">15090561</idno><idno type="local">0750689</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0022-3050</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>CGI, clinical global impression scale</term><term>MMSE, mini mental test examination</term><term>PANSS, positive and negative syndrome scale</term><term>PD, Parkinson’s disease</term><term>Parkinson’s disease</term><term>UPDRS, unified Parkinson’s disease rating scale</term><term>clozapine</term><term>psychosis</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objective: To compare the efficacy and safety of clozapine in drug induced psychosis in Parkinson’s disease (PD). Methods: A four week, randomised, double blind, parallel comparison of clozapine and placebo, followed by a 12 week clozapine open period, plus a one month period after drug discontinuation, in 60 patients with PD. The primary efficacy outcome was the “clinical global impression scale” (CGI); the positive subscore of the “positive and negative syndrome scale” (PANSS) was used as the secondary efficacy parameter and the “unified Parkinson’s disease rating scale” (UPDRS) and the “mini mental test examination” (MMSE) as safety outcomes. Results: The mean (SD) dosage of clozapine was 35.8 (12.5–50) mg at the end of the double blind period. The mean (SD) scores on the CGI improved by 1.8 (1.5) for the clozapine group compared with 0.6 (1.1) for the placebo group (p = 0.001). The mean (SD) positive subscore of PANSS improved by 5.6 (3.9) for the clozapine group (0.8 (2.8) for the placebo group; p < 0.0001). At the end of the open period, 25 patients had completely recovered from delusions and hallucinations, and 19 experienced a relapse within one month after the clozapine washout period. The UPDRS motor and MMSE mean scores did not change significantly in either group. Somnolence was more frequent with clozapine than with placebo. Conclusions: Clozapine at a mean dose lower than 50 mg/day improves drug induced psychosis in PD without significant worsening of motor function, and the effect wears off once the treatment stops.</div></front></TEI><istex><corpusName>bmj</corpusName><author><json:item><name>P Pollak</name><affiliations><json:string>Department of Neurology, University Hospital of Grenoble, 38043 Grenoble Cedex 9, France</json:string></affiliations></json:item><json:item><name>F Tison</name><affiliations><json:string>Fédération de Neurologie, University Hospital of Bordeaux, 33604 Pessac, France</json:string></affiliations></json:item><json:item><name>O Rascol</name><affiliations><json:string>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U455, CHU Purpan, 31073 Toulouse University Hospital, France</json:string></affiliations></json:item><json:item><name>A Destée</name><affiliations><json:string>Neurology and Movement Disorders Unit, Neurologie A, Hôpital Salengro, 59037 Lille, France</json:string></affiliations></json:item><json:item><name>J J Péré</name><affiliations><json:string>Novartis Pharma, 92506 Rueil-Malmaison, France</json:string></affiliations></json:item><json:item><name>J M Senard</name><affiliations><json:string>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U455, CHU Purpan, 31073 Toulouse University Hospital, France</json:string></affiliations></json:item><json:item><name>F Durif</name><affiliations><json:string>Fédération de Neurologie, Hôpital Gabriel Montpied, 63033 Clermont-Ferrand Cedex I, France</json:string></affiliations></json:item><json:item><name>I Bourdeix</name><affiliations><json:string>Novartis Pharma, 92506 Rueil-Malmaison, France</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Papers</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Psychotic disorders (incl schizophrenia)</value></json:item><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><json:item><lang><json:string>eng</json:string></lang><value>CGI, clinical global impression scale</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>MMSE, mini mental test examination</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>PANSS, positive and negative syndrome scale</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>PD, Parkinson’s disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>UPDRS, unified Parkinson’s disease rating scale</value></json:item></subject><language><json:string>eng</json:string></language><abstract>Objective: To compare the efficacy and safety of clozapine in drug induced psychosis in Parkinson’s disease (PD). Methods: A four week, randomised, double blind, parallel comparison of clozapine and placebo, followed by a 12 week clozapine open period, plus a one month period after drug discontinuation, in 60 patients with PD. The primary efficacy outcome was the “clinical global impression scale” (CGI); the positive subscore of the “positive and negative syndrome scale” (PANSS) was used as the secondary efficacy parameter and the “unified Parkinson’s disease rating scale” (UPDRS) and the “mini mental test examination” (MMSE) as safety outcomes. Results: The mean (SD) dosage of clozapine was 35.8 (12.5–50) mg at the end of the double blind period. The mean (SD) scores on the CGI improved by 1.8 (1.5) for the clozapine group compared with 0.6 (1.1) for the placebo group (p = 0.001). The mean (SD) positive subscore of PANSS improved by 5.6 (3.9) for the clozapine group (0.8 (2.8) for the placebo group; p > 0.0001). At the end of the open period, 25 patients had completely recovered from delusions and hallucinations, and 19 experienced a relapse within one month after the clozapine washout period. The UPDRS motor and MMSE mean scores did not change significantly in either group. Somnolence was more frequent with clozapine than with placebo. Conclusions: Clozapine at a mean dose lower than 50 mg/day improves drug induced psychosis in PD without significant worsening of motor function, and the effect wears off once the treatment stops.</abstract><qualityIndicators><score>7.79</score><pdfVersion>1.2</pdfVersion><pdfPageSize>609.08 x 790.583 pts</pdfPageSize><refBibsNative>false</refBibsNative><keywordCount>10</keywordCount><abstractCharCount>1558</abstractCharCount><pdfWordCount>4790</pdfWordCount><pdfCharCount>30366</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>250</abstractWordCount></qualityIndicators><title>Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up</title><pmid><json:string>15090561</json:string></pmid><genre><json:string>research-article</json:string></genre><host><volume>75</volume><pages><first>689</first></pages><issn><json:string>0022-3050</json:string></issn><issue>5</issue><genre></genre><language><json:string>unknown</json:string></language><eissn><json:string>1468-330X</json:string></eissn><title>Journal of Neurology, Neurosurgery & Psychiatry</title></host><publicationDate>2004</publicationDate><copyrightDate>2004</copyrightDate><doi><json:string>10.1136/jnnp.2003.029868</json:string></doi><id>D8CE96F619CD308F9DD33D29A5CCFC4FF3A19292</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/D8CE96F619CD308F9DD33D29A5CCFC4FF3A19292/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/D8CE96F619CD308F9DD33D29A5CCFC4FF3A19292/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/D8CE96F619CD308F9DD33D29A5CCFC4FF3A19292/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up</title><respStmt xml:id="ISTEX-API" resp="Références bibliographiques récupérées via GROBID" name="ISTEX-API (INIST-CNRS)"></respStmt></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>BMJ Publishing Group Ltd</publisher><availability><p>BMJ</p></availability><date>2004-04-16</date></publicationStmt><notesStmt><note>Correspondence to:
Dr P Pollak
Départment de Neurologie, Centre Hospitalier Universitaire de Grenoble, BP 217 X, 38043 Grenoble Cedex 9, France; pierre.pollak@ujf-grenoble.fr</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up</title><author><persName><forename type="first">P</forename><surname>Pollak</surname></persName><affiliation>Department of Neurology, University Hospital of Grenoble, 38043 Grenoble Cedex 9, France</affiliation></author><author><persName><forename type="first">F</forename><surname>Tison</surname></persName><affiliation>Fédération de Neurologie, University Hospital of Bordeaux, 33604 Pessac, France</affiliation></author><author><persName><forename type="first">O</forename><surname>Rascol</surname></persName><affiliation>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U455, CHU Purpan, 31073 Toulouse University Hospital, France</affiliation></author><author><persName><forename type="first">A</forename><surname>Destée</surname></persName><affiliation>Neurology and Movement Disorders Unit, Neurologie A, Hôpital Salengro, 59037 Lille, France</affiliation></author><author><persName><forename type="first">J J</forename><surname>Péré</surname></persName><affiliation>Novartis Pharma, 92506 Rueil-Malmaison, France</affiliation></author><author><persName><forename type="first">J M</forename><surname>Senard</surname></persName><affiliation>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U455, CHU Purpan, 31073 Toulouse University Hospital, France</affiliation></author><author><persName><forename type="first">F</forename><surname>Durif</surname></persName><affiliation>Fédération de Neurologie, Hôpital Gabriel Montpied, 63033 Clermont-Ferrand Cedex I, France</affiliation></author><author><persName><forename type="first">I</forename><surname>Bourdeix</surname></persName><affiliation>Novartis Pharma, 92506 Rueil-Malmaison, France</affiliation></author></analytic><monogr><title level="j">Journal of Neurology, Neurosurgery & Psychiatry</title><title level="j" type="abbrev">J Neurol Neurosurg Psychiatry</title><idno type="pISSN">0022-3050</idno><idno type="eISSN">1468-330X</idno><imprint><publisher>BMJ Publishing Group Ltd</publisher><date type="published" when="2004-05"></date><biblScope unit="volume">75</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="689">689</biblScope></imprint></monogr><idno type="istex">D8CE96F619CD308F9DD33D29A5CCFC4FF3A19292</idno><idno type="DOI">10.1136/jnnp.2003.029868</idno><idno type="href">jnnp-75-689.pdf</idno><idno type="PMID">15090561</idno><idno type="local">0750689</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2004-04-16</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Objective: To compare the efficacy and safety of clozapine in drug induced psychosis in Parkinson’s disease (PD). Methods: A four week, randomised, double blind, parallel comparison of clozapine and placebo, followed by a 12 week clozapine open period, plus a one month period after drug discontinuation, in 60 patients with PD. The primary efficacy outcome was the “clinical global impression scale” (CGI); the positive subscore of the “positive and negative syndrome scale” (PANSS) was used as the secondary efficacy parameter and the “unified Parkinson’s disease rating scale” (UPDRS) and the “mini mental test examination” (MMSE) as safety outcomes. Results: The mean (SD) dosage of clozapine was 35.8 (12.5–50) mg at the end of the double blind period. The mean (SD) scores on the CGI improved by 1.8 (1.5) for the clozapine group compared with 0.6 (1.1) for the placebo group (p = 0.001). The mean (SD) positive subscore of PANSS improved by 5.6 (3.9) for the clozapine group (0.8 (2.8) for the placebo group; p < 0.0001). At the end of the open period, 25 patients had completely recovered from delusions and hallucinations, and 19 experienced a relapse within one month after the clozapine washout period. The UPDRS motor and MMSE mean scores did not change significantly in either group. Somnolence was more frequent with clozapine than with placebo. Conclusions: Clozapine at a mean dose lower than 50 mg/day improves drug induced psychosis in PD without significant worsening of motor function, and the effect wears off once the treatment stops.</p></abstract><textClass><keywords scheme="keyword"><list><head>hwp-journal-coll</head><item><term>Psychotic disorders (incl schizophrenia)</term></item></list></keywords></textClass><textClass xml:lang="en"><keywords scheme="keyword"><list><head>KWD</head><item><term>Parkinson’s disease</term></item><item><term>psychosis</term></item><item><term>clozapine</term></item></list></keywords></textClass><textClass xml:lang="en"><keywords scheme="keyword"><list><head>ABR</head><item><term>CGI, clinical global impression scale</term></item><item><term>MMSE, mini mental test examination</term></item><item><term>PANSS, positive and negative syndrome scale</term></item><item><term>PD, Parkinson’s disease</term></item><item><term>UPDRS, unified Parkinson’s disease rating scale</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2004-04-16">Created</change><change when="2004-05">Published</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2016-3-14">References added</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/D8CE96F619CD308F9DD33D29A5CCFC4FF3A19292/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article xml:lang="en" article-type="research-article"><front><journal-meta><journal-id journal-id-type="hwp">jnnp</journal-id><journal-id journal-id-type="nlm-ta">J Neurol Neurosurg Psychiatry</journal-id><journal-title>Journal of Neurology, Neurosurgery & Psychiatry</journal-title><abbrev-journal-title abbrev-type="publisher">J Neurol Neurosurg Psychiatry</abbrev-journal-title><issn pub-type="ppub">0022-3050</issn><issn pub-type="epub">1468-330X</issn><publisher><publisher-name>BMJ Publishing Group Ltd</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="other">0750689</article-id><article-id pub-id-type="doi">10.1136/jnnp.2003.029868</article-id><article-id pub-id-type="other">jnnp;75/5/689</article-id><article-id pub-id-type="pmid">15090561</article-id><article-id pub-id-type="other">689</article-id><article-id pub-id-type="other">jnnp.2003.029868</article-id><article-categories><subj-group subj-group-type="heading"><subject content-type="original">Papers</subject></subj-group><subj-group subj-group-type="hwp-journal-coll"><subject>Psychotic disorders (incl schizophrenia)</subject></subj-group></article-categories><title-group><article-title>Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up</article-title></title-group><contrib-group><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Pollak</surname><given-names>P</given-names></name><xref rid="AFF1">1</xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Tison</surname><given-names>F</given-names></name><xref rid="AFF2">2</xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Rascol</surname><given-names>O</given-names></name><xref rid="AFF3">3</xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Destée</surname><given-names>A</given-names></name><xref rid="AFF4">4</xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Péré</surname><given-names>J J</given-names></name><xref rid="AFF5">5</xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Senard</surname><given-names>J M</given-names></name><xref rid="AFF3">3</xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Durif</surname><given-names>F</given-names></name><xref rid="AFF6">6</xref></contrib><contrib contrib-type="author" xlink:type="simple"><name name-style="western"><surname>Bourdeix</surname><given-names>I</given-names></name><xref rid="AFF5">5</xref></contrib><contrib contrib-type="group-author" xlink:type="simple"><on-behalf-of>on behalf of the French Clozapine Parkinson Study Group</on-behalf-of></contrib><aff id="AFF1"><label>1</label>Department of Neurology, University Hospital of Grenoble, 38043 Grenoble Cedex 9, France</aff><aff id="AFF2"><label>2</label>Fédération de Neurologie, University Hospital of Bordeaux, 33604 Pessac, France</aff><aff id="AFF3"><label>3</label>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U455, CHU Purpan, 31073 Toulouse University Hospital, France</aff><aff id="AFF4"><label>4</label>Neurology and Movement Disorders Unit, Neurologie A, Hôpital Salengro, 59037 Lille, France</aff><aff id="AFF5"><label>5</label>Novartis Pharma, 92506 Rueil-Malmaison, France</aff><aff id="AFF6"><label>6</label>Fédération de Neurologie, Hôpital Gabriel Montpied, 63033 Clermont-Ferrand Cedex I, France</aff></contrib-group><author-notes><corresp>Correspondence to:
Dr P Pollak
Départment de Neurologie, Centre Hospitalier Universitaire de Grenoble, BP 217 X, 38043 Grenoble Cedex 9, France; <ext-link xlink:href="pierre.pollakujf-grenoble.fr" ext-link-type="email" xlink:type="simple">pierre.pollak@ujf-grenoble.fr</ext-link></corresp></author-notes><pub-date pub-type="ppub"><month>5</month><year>2004</year></pub-date><pub-date pub-type="epub"><day>16</day><month>4</month><year>2004</year></pub-date><volume>75</volume><volume-id pub-id-type="other">75</volume-id><volume-id pub-id-type="other">75</volume-id><issue>5</issue><issue-id pub-id-type="other">jnnp;75/5</issue-id><issue-id pub-id-type="other">5</issue-id><issue-id pub-id-type="other">75/5</issue-id><fpage>689</fpage><history><date date-type="accepted"><day>07</day><month>10</month><year>2003</year></date><date date-type="received"><day>07</day><month>10</month><year>2003</year></date></history><permissions><copyright-statement>Copyright 2004 Journal of Neurology Neurosurgery and Psychiatry</copyright-statement><copyright-year>2004</copyright-year></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="jnnp-75-689.pdf"></self-uri><abstract xml:lang="en"><p><bold>Objective:</bold> To compare the efficacy and safety of clozapine in drug induced psychosis in Parkinson’s disease (PD).</p><p><bold>Methods:</bold> A four week, randomised, double blind, parallel comparison of clozapine and placebo, followed by a 12 week clozapine open period, plus a one month period after drug discontinuation, in 60 patients with PD. The primary efficacy outcome was the “clinical global impression scale” (CGI); the positive subscore of the “positive and negative syndrome scale” (PANSS) was used as the secondary efficacy parameter and the “unified Parkinson’s disease rating scale” (UPDRS) and the “mini mental test examination” (MMSE) as safety outcomes.</p><p><bold>Results:</bold> The mean (SD) dosage of clozapine was 35.8 (12.5–50) mg at the end of the double blind period. The mean (SD) scores on the CGI improved by 1.8 (1.5) for the clozapine group compared with 0.6 (1.1) for the placebo group (p = 0.001). The mean (SD) positive subscore of PANSS improved by 5.6 (3.9) for the clozapine group (0.8 (2.8) for the placebo group; p < 0.0001). At the end of the open period, 25 patients had completely recovered from delusions and hallucinations, and 19 experienced a relapse within one month after the clozapine washout period. The UPDRS motor and MMSE mean scores did not change significantly in either group. Somnolence was more frequent with clozapine than with placebo.</p><p><bold>Conclusions:</bold> Clozapine at a mean dose lower than 50 mg/day improves drug induced psychosis in PD without significant worsening of motor function, and the effect wears off once the treatment stops.</p></abstract><kwd-group kwd-group-type="KWD" xml:lang="en"><kwd>Parkinson’s disease</kwd><kwd>psychosis</kwd><kwd>clozapine</kwd></kwd-group><kwd-group kwd-group-type="ABR" xml:lang="en"><kwd>CGI, clinical global impression scale</kwd><kwd>MMSE, mini mental test examination</kwd><kwd>PANSS, positive and negative syndrome scale</kwd><kwd>PD, Parkinson’s disease</kwd><kwd>UPDRS, unified Parkinson’s disease rating scale</kwd></kwd-group></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up</title></titleInfo><name type="personal"><namePart type="given">P</namePart><namePart type="family">Pollak</namePart><affiliation>Department of Neurology, University Hospital of Grenoble, 38043 Grenoble Cedex 9, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">F</namePart><namePart type="family">Tison</namePart><affiliation>Fédération de Neurologie, University Hospital of Bordeaux, 33604 Pessac, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">O</namePart><namePart type="family">Rascol</namePart><affiliation>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U455, CHU Purpan, 31073 Toulouse University Hospital, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A</namePart><namePart type="family">Destée</namePart><affiliation>Neurology and Movement Disorders Unit, Neurologie A, Hôpital Salengro, 59037 Lille, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J J</namePart><namePart type="family">Péré</namePart><affiliation>Novartis Pharma, 92506 Rueil-Malmaison, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J M</namePart><namePart type="family">Senard</namePart><affiliation>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U455, CHU Purpan, 31073 Toulouse University Hospital, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">F</namePart><namePart type="family">Durif</namePart><affiliation>Fédération de Neurologie, Hôpital Gabriel Montpied, 63033 Clermont-Ferrand Cedex I, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">I</namePart><namePart type="family">Bourdeix</namePart><affiliation>Novartis Pharma, 92506 Rueil-Malmaison, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article"></genre><subject><genre>hwp-journal-coll</genre><topic>Psychotic disorders (incl schizophrenia)</topic></subject><originInfo><publisher>BMJ Publishing Group Ltd</publisher><dateIssued encoding="w3cdtf">2004-05</dateIssued><dateCreated encoding="w3cdtf">2004-04-16</dateCreated><copyrightDate encoding="w3cdtf">2004</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">Objective: To compare the efficacy and safety of clozapine in drug induced psychosis in Parkinson’s disease (PD). Methods: A four week, randomised, double blind, parallel comparison of clozapine and placebo, followed by a 12 week clozapine open period, plus a one month period after drug discontinuation, in 60 patients with PD. The primary efficacy outcome was the “clinical global impression scale” (CGI); the positive subscore of the “positive and negative syndrome scale” (PANSS) was used as the secondary efficacy parameter and the “unified Parkinson’s disease rating scale” (UPDRS) and the “mini mental test examination” (MMSE) as safety outcomes. Results: The mean (SD) dosage of clozapine was 35.8 (12.5–50) mg at the end of the double blind period. The mean (SD) scores on the CGI improved by 1.8 (1.5) for the clozapine group compared with 0.6 (1.1) for the placebo group (p = 0.001). The mean (SD) positive subscore of PANSS improved by 5.6 (3.9) for the clozapine group (0.8 (2.8) for the placebo group; p < 0.0001). At the end of the open period, 25 patients had completely recovered from delusions and hallucinations, and 19 experienced a relapse within one month after the clozapine washout period. The UPDRS motor and MMSE mean scores did not change significantly in either group. Somnolence was more frequent with clozapine than with placebo. Conclusions: Clozapine at a mean dose lower than 50 mg/day improves drug induced psychosis in PD without significant worsening of motor function, and the effect wears off once the treatment stops.</abstract><note type="author-notes">Correspondence to:
Dr P Pollak
Départment de Neurologie, Centre Hospitalier Universitaire de Grenoble, BP 217 X, 38043 Grenoble Cedex 9, France; pierre.pollak@ujf-grenoble.fr</note><subject lang="en"><genre>KWD</genre><topic>Parkinson’s disease</topic><topic>psychosis</topic><topic>clozapine</topic></subject><subject lang="en"><genre>ABR</genre><topic>CGI, clinical global impression scale</topic><topic>MMSE, mini mental test examination</topic><topic>PANSS, positive and negative syndrome scale</topic><topic>PD, Parkinson’s disease</topic><topic>UPDRS, unified Parkinson’s disease rating scale</topic></subject><relatedItem type="host"><titleInfo><title>Journal of Neurology, Neurosurgery & Psychiatry</title></titleInfo><titleInfo type="abbreviated"><title>J Neurol Neurosurg Psychiatry</title></titleInfo><genre type="Journal">journal</genre><identifier type="ISSN">0022-3050</identifier><identifier type="eISSN">1468-330X</identifier><identifier type="PublisherID-hwp">jnnp</identifier><identifier type="PublisherID-nlm-ta">J Neurol Neurosurg Psychiatry</identifier><part><date>2004</date><detail type="volume"><caption>vol.</caption><number>75</number></detail><detail type="issue"><caption>no.</caption><number>5</number></detail><extent unit="pages"><start>689</start></extent></part></relatedItem><identifier type="istex">D8CE96F619CD308F9DD33D29A5CCFC4FF3A19292</identifier><identifier type="DOI">10.1136/jnnp.2003.029868</identifier><identifier type="href">jnnp-75-689.pdf</identifier><identifier type="PMID">15090561</identifier><identifier type="local">0750689</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright 2004 Journal of Neurology Neurosurgery and Psychiatry</accessCondition><recordInfo><recordContentSource>BMJ</recordContentSource></recordInfo></mods></metadata><annexes><json:item><original>true</original><mimetype>image/jpeg</mimetype><extension>jpeg</extension><uri>https://api.istex.fr/document/D8CE96F619CD308F9DD33D29A5CCFC4FF3A19292/annexes/jpeg</uri></json:item></annexes><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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