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dc.contributor.authorRothschild, Anthony J.
dc.contributor.authorWilliamson, Douglas J.
dc.contributor.authorTohen, Mauricio F.
dc.contributor.authorSchatzberg, Alan F.
dc.contributor.authorAndersen, Scott W.
dc.contributor.authorVan Campen, Luann E.
dc.contributor.authorSanger, Todd M.
dc.contributor.authorTollefson, Gary D.
dc.date2022-08-11T08:10:28.000
dc.date.accessioned2022-08-23T17:10:33Z
dc.date.available2022-08-23T17:10:33Z
dc.date.issued2004-07-03
dc.date.submitted2010-05-05
dc.identifier.citationJ Clin Psychopharmacol. 2004 Aug;24(4):365-73.
dc.identifier.issn0271-0749 (Linking)
dc.identifier.pmid15232326
dc.identifier.urihttp://hdl.handle.net/20.500.14038/46071
dc.description.abstractThe purpose of this study was to compare the efficacy and safety of olanzapine (OLZ) monotherapy and an olanzapine/fluoxetine combination (OFC) with placebo (PLA) for unipolar major depression with psychotic features. Under a single protocol, two 8-week, double-blind trials were conducted at 27 sites. Patients (n = 124 trial 1, n = 125 trial 2) were randomized to 1 of 3 treatment groups: OLZ (5 to 20 mg/d), PLA, or OFC (olanzapine 5 to 20 mg/d + fluoxetine 20 to 80 mg/d). The primary outcome measure was the 24-item Hamilton Depression Rating Scale total score. For trial 1, endpoint improvement for the OLZ group (-14.9) was not significantly different from the PLA or OFC groups. The OFC group had significantly greater endpoint improvement (-20.9) than the PLA group (-10.4, P = 0.001); this significant difference was present within 7 days of therapy and maintained at every subsequent visit. The OFC group also had significantly higher response rate (63.6%) than the PLA (28.0%, P = 0.004) or OLZ (34.9%, P = 0.027) groups. For trial 2, there were no significant differences among treatment groups on the 24-item Hamilton Depression Rating Scale total scores or response rates. The combination exhibited a comparable safety profile with OLZ monotherapy and no significant increases in extrapyramidal symptoms compared with placebo. Patients with major depression with psychotic features treated with OLZ monotherapy did not demonstrate significant depressive symptom improvement compared with placebo in either trial; however, an olanzapine/fluoxetine combination was associated with significant improvement compared with placebo in one trial and was well tolerated.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=15232326&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://journals.lww.com/psychopharmacology/pages/articleviewer.aspx?year=2004&issue=08000&article=00002&type=abstract
dc.subjectAdult
dc.subjectAnalysis of Variance
dc.subjectBenzodiazepines
dc.subjectChi-Square Distribution
dc.subjectDepressive Disorder, Major
dc.subjectDouble-Blind Method
dc.subjectDrug Therapy, Combination
dc.subjectFemale
dc.subjectFluoxetine
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectPsychotic Disorders
dc.subjectPsychiatry
dc.titleA double-blind, randomized study of olanzapine and olanzapine/fluoxetine combination for major depression with psychotic features
dc.typeJournal Article
dc.source.journaltitleJournal of clinical psychopharmacology
dc.source.volume24
dc.source.issue4
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/psych_pp/60
dc.identifier.contextkey1299407
html.description.abstract<p>The purpose of this study was to compare the efficacy and safety of olanzapine (OLZ) monotherapy and an olanzapine/fluoxetine combination (OFC) with placebo (PLA) for unipolar major depression with psychotic features. Under a single protocol, two 8-week, double-blind trials were conducted at 27 sites. Patients (n = 124 trial 1, n = 125 trial 2) were randomized to 1 of 3 treatment groups: OLZ (5 to 20 mg/d), PLA, or OFC (olanzapine 5 to 20 mg/d + fluoxetine 20 to 80 mg/d). The primary outcome measure was the 24-item Hamilton Depression Rating Scale total score. For trial 1, endpoint improvement for the OLZ group (-14.9) was not significantly different from the PLA or OFC groups. The OFC group had significantly greater endpoint improvement (-20.9) than the PLA group (-10.4, P = 0.001); this significant difference was present within 7 days of therapy and maintained at every subsequent visit. The OFC group also had significantly higher response rate (63.6%) than the PLA (28.0%, P = 0.004) or OLZ (34.9%, P = 0.027) groups. For trial 2, there were no significant differences among treatment groups on the 24-item Hamilton Depression Rating Scale total scores or response rates. The combination exhibited a comparable safety profile with OLZ monotherapy and no significant increases in extrapyramidal symptoms compared with placebo. Patients with major depression with psychotic features treated with OLZ monotherapy did not demonstrate significant depressive symptom improvement compared with placebo in either trial; however, an olanzapine/fluoxetine combination was associated with significant improvement compared with placebo in one trial and was well tolerated.</p>
dc.identifier.submissionpathpsych_pp/60
dc.contributor.departmentDepartment of Psychiatry
dc.source.pages365-73


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