Onset of antidepressant effect of olanzapine and olanzapine/fluoxetine combination in bipolar depression

Objectives:  The current analysis investigated the onset of antidepressant effect of olanzapine/fluoxetine combination. Methods:  Data for these post hoc analyses were obtained from a clinical trial comparing olanzapine, placebo, and olanzapine/fluoxetine combination in bipolar depression (BD). Subj...

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Veröffentlicht in:Bipolar disorders 2007-09, Vol.9 (6), p.618-627
Hauptverfasser: Dubé, Sanjay, Tollefson, Gary D, Thase, Michael E, Briggs, Susan D, Van Campen, Luann E, Case, Michael, Tohen, Mauricio
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container_end_page 627
container_issue 6
container_start_page 618
container_title Bipolar disorders
container_volume 9
creator Dubé, Sanjay
Tollefson, Gary D
Thase, Michael E
Briggs, Susan D
Van Campen, Luann E
Case, Michael
Tohen, Mauricio
description Objectives:  The current analysis investigated the onset of antidepressant effect of olanzapine/fluoxetine combination. Methods:  Data for these post hoc analyses were obtained from a clinical trial comparing olanzapine, placebo, and olanzapine/fluoxetine combination in bipolar depression (BD). Subjects were 833 patients with a DSM‐IV diagnosis of bipolar I disorder, depressed. The Montgomery–Åsberg Depression Rating Scale measured depressive symptoms. Multiple analytic methods were applied, including traditional (mean differences) analysis, pattern analysis, survival analysis of sustained response, mixed‐effects regression, and area‐under‐the‐curve analysis. Results:  Traditional analysis showed significantly greater improvement in depression scores at week 1 for olanzapine/fluoxetine combination versus placebo (−9.55 versus −5.08, p 
doi_str_mv 10.1111/j.1399-5618.2007.00491.x
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Methods:  Data for these post hoc analyses were obtained from a clinical trial comparing olanzapine, placebo, and olanzapine/fluoxetine combination in bipolar depression (BD). Subjects were 833 patients with a DSM‐IV diagnosis of bipolar I disorder, depressed. The Montgomery–Åsberg Depression Rating Scale measured depressive symptoms. Multiple analytic methods were applied, including traditional (mean differences) analysis, pattern analysis, survival analysis of sustained response, mixed‐effects regression, and area‐under‐the‐curve analysis. Results:  Traditional analysis showed significantly greater improvement in depression scores at week 1 for olanzapine/fluoxetine combination versus placebo (−9.55 versus −5.08, p < 0.001) and for olanzapine versus placebo (−8.31 versus −5.08, p < 0.001). Pattern analysis revealed olanzapine/fluoxetine combination had a significantly greater percentage of early persistent responders than placebo or olanzapine (32.4% versus 12.7%, p < 0.001; and 18.3%, p < 0.05, respectively). Survival analysis showed a significantly shorter time to sustained response for the combination versus placebo (p < 0.001), for olanzapine versus placebo (p = 0.04), and for the combination versus olanzapine (p = 0.03). Mixed‐effects regression analysis revealed a significant therapy‐by‐time interaction (p < 0.001). Early area‐under‐the‐curve analysis revealed a significantly greater percentage of improvement for the combination versus placebo (26.7% versus 13.9%, p < 0.001) and for olanzapine versus placebo (22.0% versus 13.9%, p < 0.001). Conclusions:  Based on consistent results from related methods of measuring onset, olanzapine/fluoxetine combination demonstrated rapid onset of antidepressant effect (within 7 days) compared to placebo that was sustained over 8 weeks of treatment in a sample of BD patients. Using multiple statistical techniques may help profile a drug's onset of effect.]]></description><identifier>ISSN: 1398-5647</identifier><identifier>EISSN: 1399-5618</identifier><identifier>DOI: 10.1111/j.1399-5618.2007.00491.x</identifier><identifier>PMID: 17845277</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>antidepressive agents ; antipsychotic agents ; Antipsychotic Agents - adverse effects ; Antipsychotic Agents - therapeutic use ; Benzodiazepines - administration &amp; dosage ; Benzodiazepines - adverse effects ; bipolar disorder ; Bipolar Disorder - drug therapy ; depression ; Depressive Disorder - drug therapy ; drug combinations ; Drug Therapy, Combination ; Female ; Fluoxetine - administration &amp; dosage ; Fluoxetine - adverse effects ; Humans ; Male ; Randomized Controlled Trials as Topic ; Regression Analysis ; serotonin uptake inhibitors ; Survival Analysis ; Treatment Outcome</subject><ispartof>Bipolar disorders, 2007-09, Vol.9 (6), p.618-627</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5011-1740443a17fdd06570fb91c0b9714ff051773321fcf480f318182047be26bec43</citedby><cites>FETCH-LOGICAL-c5011-1740443a17fdd06570fb91c0b9714ff051773321fcf480f318182047be26bec43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1399-5618.2007.00491.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1399-5618.2007.00491.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1416,27923,27924,45573,45574</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17845277$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dubé, Sanjay</creatorcontrib><creatorcontrib>Tollefson, Gary D</creatorcontrib><creatorcontrib>Thase, Michael E</creatorcontrib><creatorcontrib>Briggs, Susan D</creatorcontrib><creatorcontrib>Van Campen, Luann E</creatorcontrib><creatorcontrib>Case, Michael</creatorcontrib><creatorcontrib>Tohen, Mauricio</creatorcontrib><title>Onset of antidepressant effect of olanzapine and olanzapine/fluoxetine combination in bipolar depression</title><title>Bipolar disorders</title><addtitle>Bipolar Disord</addtitle><description><![CDATA[Objectives:  The current analysis investigated the onset of antidepressant effect of olanzapine/fluoxetine combination. Methods:  Data for these post hoc analyses were obtained from a clinical trial comparing olanzapine, placebo, and olanzapine/fluoxetine combination in bipolar depression (BD). Subjects were 833 patients with a DSM‐IV diagnosis of bipolar I disorder, depressed. The Montgomery–Åsberg Depression Rating Scale measured depressive symptoms. Multiple analytic methods were applied, including traditional (mean differences) analysis, pattern analysis, survival analysis of sustained response, mixed‐effects regression, and area‐under‐the‐curve analysis. Results:  Traditional analysis showed significantly greater improvement in depression scores at week 1 for olanzapine/fluoxetine combination versus placebo (−9.55 versus −5.08, p < 0.001) and for olanzapine versus placebo (−8.31 versus −5.08, p < 0.001). Pattern analysis revealed olanzapine/fluoxetine combination had a significantly greater percentage of early persistent responders than placebo or olanzapine (32.4% versus 12.7%, p < 0.001; and 18.3%, p < 0.05, respectively). Survival analysis showed a significantly shorter time to sustained response for the combination versus placebo (p < 0.001), for olanzapine versus placebo (p = 0.04), and for the combination versus olanzapine (p = 0.03). Mixed‐effects regression analysis revealed a significant therapy‐by‐time interaction (p < 0.001). Early area‐under‐the‐curve analysis revealed a significantly greater percentage of improvement for the combination versus placebo (26.7% versus 13.9%, p < 0.001) and for olanzapine versus placebo (22.0% versus 13.9%, p < 0.001). Conclusions:  Based on consistent results from related methods of measuring onset, olanzapine/fluoxetine combination demonstrated rapid onset of antidepressant effect (within 7 days) compared to placebo that was sustained over 8 weeks of treatment in a sample of BD patients. Using multiple statistical techniques may help profile a drug's onset of effect.]]></description><subject>antidepressive agents</subject><subject>antipsychotic agents</subject><subject>Antipsychotic Agents - adverse effects</subject><subject>Antipsychotic Agents - therapeutic use</subject><subject>Benzodiazepines - administration &amp; dosage</subject><subject>Benzodiazepines - adverse effects</subject><subject>bipolar disorder</subject><subject>Bipolar Disorder - drug therapy</subject><subject>depression</subject><subject>Depressive Disorder - drug therapy</subject><subject>drug combinations</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Fluoxetine - administration &amp; dosage</subject><subject>Fluoxetine - adverse effects</subject><subject>Humans</subject><subject>Male</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Regression Analysis</subject><subject>serotonin uptake inhibitors</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><issn>1398-5647</issn><issn>1399-5618</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkEtPwzAQhC0EgvL4Cygnbgm7iWMnEhcor0oIJASCm5XHWrikSYhT0fLrcdoKOOKLx96ZsfUx5iEE6NbpNMAoTf1YYBKEADIA4CkGiy02-hlsr3TiNJd7bN_aKQCKEOJdtocy4XEo5Yi9PdSWeq_RXlb3pqS2I2ud9EhrKlaDpsrqr6w1NTlP-ed4qqt5s6B-mBTNLDd11pum9kzt5aZ1vs7bFLrbQ7ajs8rS0WY_YM_XV0_jW__u4WYyPr_zixgQfZQcOI8ylLosQcQSdJ5iAXkqkWsNMUoZRSHqQvMEdIQJJiFwmVMocip4dMBO1r1t13zMyfZqZmxBlfs1NXOrHAAQiRDOmKyNRddY25FWbWdmWbdUCGqgrKZqgKkGmGqgrFaU1cJFjzdvzPMZlb_BDVZnOFsbPk1Fy38Xq4vLiRMu7q_jxva0-Iln3bsSMpKxerm_UfzyUYr4FdV19A2YFZsY</recordid><startdate>200709</startdate><enddate>200709</enddate><creator>Dubé, Sanjay</creator><creator>Tollefson, Gary D</creator><creator>Thase, Michael E</creator><creator>Briggs, Susan D</creator><creator>Van Campen, Luann E</creator><creator>Case, Michael</creator><creator>Tohen, Mauricio</creator><general>Blackwell Publishing 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>7TK</scope></search><sort><creationdate>200709</creationdate><title>Onset of antidepressant effect of olanzapine and olanzapine/fluoxetine combination in bipolar depression</title><author>Dubé, Sanjay ; Tollefson, Gary D ; Thase, Michael E ; Briggs, Susan D ; Van Campen, Luann E ; Case, Michael ; Tohen, Mauricio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5011-1740443a17fdd06570fb91c0b9714ff051773321fcf480f318182047be26bec43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>antidepressive agents</topic><topic>antipsychotic agents</topic><topic>Antipsychotic Agents - adverse effects</topic><topic>Antipsychotic Agents - therapeutic use</topic><topic>Benzodiazepines - administration &amp; dosage</topic><topic>Benzodiazepines - adverse effects</topic><topic>bipolar disorder</topic><topic>Bipolar Disorder - drug therapy</topic><topic>depression</topic><topic>Depressive Disorder - drug therapy</topic><topic>drug combinations</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Fluoxetine - administration &amp; dosage</topic><topic>Fluoxetine - adverse effects</topic><topic>Humans</topic><topic>Male</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Regression Analysis</topic><topic>serotonin uptake inhibitors</topic><topic>Survival Analysis</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dubé, Sanjay</creatorcontrib><creatorcontrib>Tollefson, Gary D</creatorcontrib><creatorcontrib>Thase, Michael E</creatorcontrib><creatorcontrib>Briggs, Susan D</creatorcontrib><creatorcontrib>Van Campen, Luann E</creatorcontrib><creatorcontrib>Case, Michael</creatorcontrib><creatorcontrib>Tohen, Mauricio</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>Neurosciences Abstracts</collection><jtitle>Bipolar disorders</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dubé, Sanjay</au><au>Tollefson, Gary D</au><au>Thase, Michael E</au><au>Briggs, Susan D</au><au>Van Campen, Luann E</au><au>Case, Michael</au><au>Tohen, Mauricio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Onset of antidepressant effect of olanzapine and olanzapine/fluoxetine combination in bipolar depression</atitle><jtitle>Bipolar disorders</jtitle><addtitle>Bipolar Disord</addtitle><date>2007-09</date><risdate>2007</risdate><volume>9</volume><issue>6</issue><spage>618</spage><epage>627</epage><pages>618-627</pages><issn>1398-5647</issn><eissn>1399-5618</eissn><abstract><![CDATA[Objectives:  The current analysis investigated the onset of antidepressant effect of olanzapine/fluoxetine combination. Methods:  Data for these post hoc analyses were obtained from a clinical trial comparing olanzapine, placebo, and olanzapine/fluoxetine combination in bipolar depression (BD). Subjects were 833 patients with a DSM‐IV diagnosis of bipolar I disorder, depressed. The Montgomery–Åsberg Depression Rating Scale measured depressive symptoms. Multiple analytic methods were applied, including traditional (mean differences) analysis, pattern analysis, survival analysis of sustained response, mixed‐effects regression, and area‐under‐the‐curve analysis. Results:  Traditional analysis showed significantly greater improvement in depression scores at week 1 for olanzapine/fluoxetine combination versus placebo (−9.55 versus −5.08, p < 0.001) and for olanzapine versus placebo (−8.31 versus −5.08, p < 0.001). Pattern analysis revealed olanzapine/fluoxetine combination had a significantly greater percentage of early persistent responders than placebo or olanzapine (32.4% versus 12.7%, p < 0.001; and 18.3%, p < 0.05, respectively). Survival analysis showed a significantly shorter time to sustained response for the combination versus placebo (p < 0.001), for olanzapine versus placebo (p = 0.04), and for the combination versus olanzapine (p = 0.03). Mixed‐effects regression analysis revealed a significant therapy‐by‐time interaction (p < 0.001). Early area‐under‐the‐curve analysis revealed a significantly greater percentage of improvement for the combination versus placebo (26.7% versus 13.9%, p < 0.001) and for olanzapine versus placebo (22.0% versus 13.9%, p < 0.001). Conclusions:  Based on consistent results from related methods of measuring onset, olanzapine/fluoxetine combination demonstrated rapid onset of antidepressant effect (within 7 days) compared to placebo that was sustained over 8 weeks of treatment in a sample of BD patients. Using multiple statistical techniques may help profile a drug's onset of effect.]]></abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>17845277</pmid><doi>10.1111/j.1399-5618.2007.00491.x</doi><tpages>10</tpages></addata></record>
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subjects antidepressive agents
antipsychotic agents
Antipsychotic Agents - adverse effects
Antipsychotic Agents - therapeutic use
Benzodiazepines - administration & dosage
Benzodiazepines - adverse effects
bipolar disorder
Bipolar Disorder - drug therapy
depression
Depressive Disorder - drug therapy
drug combinations
Drug Therapy, Combination
Female
Fluoxetine - administration & dosage
Fluoxetine - adverse effects
Humans
Male
Randomized Controlled Trials as Topic
Regression Analysis
serotonin uptake inhibitors
Survival Analysis
Treatment Outcome
title Onset of antidepressant effect of olanzapine and olanzapine/fluoxetine combination in bipolar depression
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