Granisetron as an add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: Randomized double-blind placebo-controlled study
Abstract Some 5-HT3 antagonists such as ondansetron have shown beneficial effects on negative symptoms of patients with schizophrenia. We aimed to evaluate the efficacy of granisetron (another 5-HT3 antagonist) add-on therapy in the treatment of negative symptoms of patients with stable schizophreni...
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| Veröffentlicht in: | Journal of psychiatric research 2013-04, Vol.47 (4), p.472-478 |
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| creator | Khodaie-Ardakani, Mohammad-Reza Seddighi, Sahar Modabbernia, Amirhossein Rezaei, Farzin Salehi, Bahman Ashrafi, Mandana Shams-Alizadeh, Narges Mohammad-Karimi, Maryam Esfandiari, Gholam-Reza Hajiaghaee, Reza Akhondzadeh, Shahin |
| description | Abstract Some 5-HT3 antagonists such as ondansetron have shown beneficial effects on negative symptoms of patients with schizophrenia. We aimed to evaluate the efficacy of granisetron (another 5-HT3 antagonist) add-on therapy in the treatment of negative symptoms of patients with stable schizophrenia. In a randomized, double-blind, and placebo-controlled study, forty stable patients with schizophrenia (DSM-IV-TR), were randomized to either granisetron (1 mg twice daily) or placebo (twice daily) in addition to risperidone up to 6 mg/day for eight weeks. The patients were assessed using positive and negative syndrome scale (PANSS) and extrapyramidal symptom rating scale (ESRS) at baseline, week 4 and 8. Hamilton depression rating scale (HDRS) was used to assess depression at baseline and week 8. Thirty-eight patients completed the trial. Granisetron group showed a significantly greater improvement on negative subscale than the placebo group at endpoint [ t (38) = 6.046, mean difference (±95% CI) = 3.2(1.8–3.7), P |
| doi_str_mv | 10.1016/j.jpsychires.2013.01.011 |
| format | Article |
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We aimed to evaluate the efficacy of granisetron (another 5-HT3 antagonist) add-on therapy in the treatment of negative symptoms of patients with stable schizophrenia. In a randomized, double-blind, and placebo-controlled study, forty stable patients with schizophrenia (DSM-IV-TR), were randomized to either granisetron (1 mg twice daily) or placebo (twice daily) in addition to risperidone up to 6 mg/day for eight weeks. The patients were assessed using positive and negative syndrome scale (PANSS) and extrapyramidal symptom rating scale (ESRS) at baseline, week 4 and 8. Hamilton depression rating scale (HDRS) was used to assess depression at baseline and week 8. Thirty-eight patients completed the trial. Granisetron group showed a significantly greater improvement on negative subscale than the placebo group at endpoint [ t (38) = 6.046, mean difference (±95% CI) = 3.2(1.8–3.7), P < 0.001]. The same effect was observed for total score [ t (38) = 4.168, mean difference (95% CI) = 3.2(1.6–4.7), P < 0.001]. However the placebo and granisetron groups did not differ in their reduction of positive and general psychopathology symptoms scores. HDRS scores and its changes did not differ between the two groups. The ESRS score at week 4 was significantly lower in the granisetron than the placebo group while the two groups showed similar ESRS score at week 8. Frequency of other side effects was similar between the two groups. In summary, granisetron add-on can safely and effectively reduce the primary negative symptoms of patients with schizophrenia.</description><identifier>ISSN: 0022-3956</identifier><identifier>EISSN: 1879-1379</identifier><identifier>DOI: 10.1016/j.jpsychires.2013.01.011</identifier><identifier>PMID: 23375406</identifier><identifier>CODEN: JPYRA3</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>5-HT3 antagonists ; Add-on ; Adolescent ; Adult ; Adult and adolescent clinical studies ; Antagonists ; Antipsychotic Agents - therapeutic use ; Biological and medical sciences ; Depression ; Double-Blind Method ; Drug Therapy, Combination - methods ; Female ; Granisetron ; Granisetron - therapeutic use ; Humans ; Male ; Medical sciences ; Middle Aged ; Negative symptoms ; Neuropharmacology ; Pharmacology. Drug treatments ; Primary ; Psychiatric Status Rating Scales - statistics & numerical data ; Psychiatry ; Psycholeptics: tranquillizer, neuroleptic ; Psychology. Psychoanalysis. Psychiatry ; Psychopathology ; Psychopathology. Psychiatry ; Psychopharmacology ; Psychoses ; Risperidone ; Risperidone - therapeutic use ; Schizophrenia ; Schizophrenia - drug therapy ; Schizophrenic Psychology ; Symptoms ; Treatment Outcome ; Young Adult</subject><ispartof>Journal of psychiatric research, 2013-04, Vol.47 (4), p.472-478</ispartof><rights>Elsevier Ltd</rights><rights>2013 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2013 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c641t-3fc99193de2c8413a111da9dc2fd70885381c0d34d6893b56530db1e529fb4963</citedby><cites>FETCH-LOGICAL-c641t-3fc99193de2c8413a111da9dc2fd70885381c0d34d6893b56530db1e529fb4963</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jpsychires.2013.01.011$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,781,785,3551,27929,27930,31005,46000</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27058559$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23375406$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Khodaie-Ardakani, Mohammad-Reza</creatorcontrib><creatorcontrib>Seddighi, Sahar</creatorcontrib><creatorcontrib>Modabbernia, Amirhossein</creatorcontrib><creatorcontrib>Rezaei, Farzin</creatorcontrib><creatorcontrib>Salehi, Bahman</creatorcontrib><creatorcontrib>Ashrafi, Mandana</creatorcontrib><creatorcontrib>Shams-Alizadeh, Narges</creatorcontrib><creatorcontrib>Mohammad-Karimi, Maryam</creatorcontrib><creatorcontrib>Esfandiari, Gholam-Reza</creatorcontrib><creatorcontrib>Hajiaghaee, Reza</creatorcontrib><creatorcontrib>Akhondzadeh, Shahin</creatorcontrib><title>Granisetron as an add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: Randomized double-blind placebo-controlled study</title><title>Journal of psychiatric research</title><addtitle>J Psychiatr Res</addtitle><description>Abstract Some 5-HT3 antagonists such as ondansetron have shown beneficial effects on negative symptoms of patients with schizophrenia. We aimed to evaluate the efficacy of granisetron (another 5-HT3 antagonist) add-on therapy in the treatment of negative symptoms of patients with stable schizophrenia. In a randomized, double-blind, and placebo-controlled study, forty stable patients with schizophrenia (DSM-IV-TR), were randomized to either granisetron (1 mg twice daily) or placebo (twice daily) in addition to risperidone up to 6 mg/day for eight weeks. The patients were assessed using positive and negative syndrome scale (PANSS) and extrapyramidal symptom rating scale (ESRS) at baseline, week 4 and 8. Hamilton depression rating scale (HDRS) was used to assess depression at baseline and week 8. Thirty-eight patients completed the trial. Granisetron group showed a significantly greater improvement on negative subscale than the placebo group at endpoint [ t (38) = 6.046, mean difference (±95% CI) = 3.2(1.8–3.7), P < 0.001]. The same effect was observed for total score [ t (38) = 4.168, mean difference (95% CI) = 3.2(1.6–4.7), P < 0.001]. However the placebo and granisetron groups did not differ in their reduction of positive and general psychopathology symptoms scores. HDRS scores and its changes did not differ between the two groups. The ESRS score at week 4 was significantly lower in the granisetron than the placebo group while the two groups showed similar ESRS score at week 8. Frequency of other side effects was similar between the two groups. In summary, granisetron add-on can safely and effectively reduce the primary negative symptoms of patients with schizophrenia.</description><subject>5-HT3 antagonists</subject><subject>Add-on</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Adult and adolescent clinical studies</subject><subject>Antagonists</subject><subject>Antipsychotic Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Depression</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination - methods</subject><subject>Female</subject><subject>Granisetron</subject><subject>Granisetron - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Negative symptoms</subject><subject>Neuropharmacology</subject><subject>Pharmacology. Drug treatments</subject><subject>Primary</subject><subject>Psychiatric Status Rating Scales - statistics & numerical data</subject><subject>Psychiatry</subject><subject>Psycholeptics: tranquillizer, neuroleptic</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychopathology</subject><subject>Psychopathology. Psychiatry</subject><subject>Psychopharmacology</subject><subject>Psychoses</subject><subject>Risperidone</subject><subject>Risperidone - therapeutic use</subject><subject>Schizophrenia</subject><subject>Schizophrenia - drug therapy</subject><subject>Schizophrenic Psychology</subject><subject>Symptoms</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0022-3956</issn><issn>1879-1379</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>7QJ</sourceid><recordid>eNqNkl2L1DAUhoso7rj6FyQ3gjcdc5p-xQvBXXQVFgQ_rkOanDoZ26YmmZXZn-Mv9ZQZXfBmB0LaJk_OeUmfLGPA18ChfrVdb-e4NxsXMK4LDmLNgQY8yFbQNjIH0ciH2YrzosiFrOqz7EmMW855U0D5ODsrhGiqkter7PdV0JOLmIKfmI5M02xtTh_Js-DijMFZPyHrfWApoE4jTon5nk34XSd3gyzuxzn5MTI3sZmWaD-yXy5tWEy6GwigoLd-3gScnH7NPuvJ-tHdomXW7wjIu8FNls2DNtj53PiJ0gwD7ce0s_un2aNeDxGfHZ_n2bf3775efsivP119vHx7nZu6hJSL3kgJUlgsTFuC0ABgtbSm6G3D27YSLRhuRWnrVoquqivBbQdYFbLvSlmL8-zloe4c_M8dxqRGFw0Og57Q76KCSpStELJpTkDpqpsGBNyPlqKtl3wnVC2LhvNW0JF7UQFFXYPgC9oeUBN8jAF7NQc36rBXwNVik9qqO5vUYpPiQGPJ_vzYZdeNaP8d_KsPAS-OgI5GDz25ZFy84xpetVUlibs4cEj_78ZhUNGQJwYt9TRJWe9OSfPmvyKGvHHU9wfuMW79LkzkhwIVC8XVl8X-RX66BXolI_4AsvsD7g</recordid><startdate>20130401</startdate><enddate>20130401</enddate><creator>Khodaie-Ardakani, Mohammad-Reza</creator><creator>Seddighi, Sahar</creator><creator>Modabbernia, Amirhossein</creator><creator>Rezaei, Farzin</creator><creator>Salehi, Bahman</creator><creator>Ashrafi, Mandana</creator><creator>Shams-Alizadeh, Narges</creator><creator>Mohammad-Karimi, Maryam</creator><creator>Esfandiari, Gholam-Reza</creator><creator>Hajiaghaee, Reza</creator><creator>Akhondzadeh, Shahin</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>IQODW</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><scope>7TK</scope><scope>7QJ</scope></search><sort><creationdate>20130401</creationdate><title>Granisetron as an add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: Randomized double-blind placebo-controlled study</title><author>Khodaie-Ardakani, Mohammad-Reza ; Seddighi, Sahar ; Modabbernia, Amirhossein ; Rezaei, Farzin ; Salehi, Bahman ; Ashrafi, Mandana ; Shams-Alizadeh, Narges ; Mohammad-Karimi, Maryam ; Esfandiari, Gholam-Reza ; Hajiaghaee, Reza ; Akhondzadeh, Shahin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c641t-3fc99193de2c8413a111da9dc2fd70885381c0d34d6893b56530db1e529fb4963</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>5-HT3 antagonists</topic><topic>Add-on</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Adult and adolescent clinical studies</topic><topic>Antagonists</topic><topic>Antipsychotic Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Depression</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination - methods</topic><topic>Female</topic><topic>Granisetron</topic><topic>Granisetron - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Negative symptoms</topic><topic>Neuropharmacology</topic><topic>Pharmacology. Drug treatments</topic><topic>Primary</topic><topic>Psychiatric Status Rating Scales - statistics & numerical data</topic><topic>Psychiatry</topic><topic>Psycholeptics: tranquillizer, neuroleptic</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychopathology</topic><topic>Psychopathology. Psychiatry</topic><topic>Psychopharmacology</topic><topic>Psychoses</topic><topic>Risperidone</topic><topic>Risperidone - therapeutic use</topic><topic>Schizophrenia</topic><topic>Schizophrenia - drug therapy</topic><topic>Schizophrenic Psychology</topic><topic>Symptoms</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Khodaie-Ardakani, Mohammad-Reza</creatorcontrib><creatorcontrib>Seddighi, Sahar</creatorcontrib><creatorcontrib>Modabbernia, Amirhossein</creatorcontrib><creatorcontrib>Rezaei, Farzin</creatorcontrib><creatorcontrib>Salehi, Bahman</creatorcontrib><creatorcontrib>Ashrafi, Mandana</creatorcontrib><creatorcontrib>Shams-Alizadeh, Narges</creatorcontrib><creatorcontrib>Mohammad-Karimi, Maryam</creatorcontrib><creatorcontrib>Esfandiari, Gholam-Reza</creatorcontrib><creatorcontrib>Hajiaghaee, Reza</creatorcontrib><creatorcontrib>Akhondzadeh, Shahin</creatorcontrib><collection>Pascal-Francis</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><collection>Neurosciences Abstracts</collection><collection>Applied Social Sciences Index & Abstracts (ASSIA)</collection><jtitle>Journal of psychiatric research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Khodaie-Ardakani, Mohammad-Reza</au><au>Seddighi, Sahar</au><au>Modabbernia, Amirhossein</au><au>Rezaei, Farzin</au><au>Salehi, Bahman</au><au>Ashrafi, Mandana</au><au>Shams-Alizadeh, Narges</au><au>Mohammad-Karimi, Maryam</au><au>Esfandiari, Gholam-Reza</au><au>Hajiaghaee, Reza</au><au>Akhondzadeh, Shahin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Granisetron as an add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: Randomized double-blind placebo-controlled study</atitle><jtitle>Journal of psychiatric research</jtitle><addtitle>J Psychiatr Res</addtitle><date>2013-04-01</date><risdate>2013</risdate><volume>47</volume><issue>4</issue><spage>472</spage><epage>478</epage><pages>472-478</pages><issn>0022-3956</issn><eissn>1879-1379</eissn><coden>JPYRA3</coden><abstract>Abstract Some 5-HT3 antagonists such as ondansetron have shown beneficial effects on negative symptoms of patients with schizophrenia. We aimed to evaluate the efficacy of granisetron (another 5-HT3 antagonist) add-on therapy in the treatment of negative symptoms of patients with stable schizophrenia. In a randomized, double-blind, and placebo-controlled study, forty stable patients with schizophrenia (DSM-IV-TR), were randomized to either granisetron (1 mg twice daily) or placebo (twice daily) in addition to risperidone up to 6 mg/day for eight weeks. The patients were assessed using positive and negative syndrome scale (PANSS) and extrapyramidal symptom rating scale (ESRS) at baseline, week 4 and 8. Hamilton depression rating scale (HDRS) was used to assess depression at baseline and week 8. Thirty-eight patients completed the trial. Granisetron group showed a significantly greater improvement on negative subscale than the placebo group at endpoint [ t (38) = 6.046, mean difference (±95% CI) = 3.2(1.8–3.7), P < 0.001]. The same effect was observed for total score [ t (38) = 4.168, mean difference (95% CI) = 3.2(1.6–4.7), P < 0.001]. However the placebo and granisetron groups did not differ in their reduction of positive and general psychopathology symptoms scores. HDRS scores and its changes did not differ between the two groups. The ESRS score at week 4 was significantly lower in the granisetron than the placebo group while the two groups showed similar ESRS score at week 8. Frequency of other side effects was similar between the two groups. In summary, granisetron add-on can safely and effectively reduce the primary negative symptoms of patients with schizophrenia.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>23375406</pmid><doi>10.1016/j.jpsychires.2013.01.011</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | 5-HT3 antagonists Add-on Adolescent Adult Adult and adolescent clinical studies Antagonists Antipsychotic Agents - therapeutic use Biological and medical sciences Depression Double-Blind Method Drug Therapy, Combination - methods Female Granisetron Granisetron - therapeutic use Humans Male Medical sciences Middle Aged Negative symptoms Neuropharmacology Pharmacology. Drug treatments Primary Psychiatric Status Rating Scales - statistics & numerical data Psychiatry Psycholeptics: tranquillizer, neuroleptic Psychology. Psychoanalysis. Psychiatry Psychopathology Psychopathology. Psychiatry Psychopharmacology Psychoses Risperidone Risperidone - therapeutic use Schizophrenia Schizophrenia - drug therapy Schizophrenic Psychology Symptoms Treatment Outcome Young Adult |
| title | Granisetron as an add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: Randomized double-blind placebo-controlled study |
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