Assessment of depressive symptoms and functional outcomes in patients with major depressive disorder treated with duloxetine versus placebo: primary outcomes from two trials conducted under the same protocol.
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| Title: | Assessment of depressive symptoms and functional outcomes in patients with major depressive disorder treated with duloxetine versus placebo: primary outcomes from two trials conducted under the same protocol. |
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| Authors: | Oakes, Tina Marie Myers, Myers, Adam L., Marangell, Lauren B., Ahl, Jonna, Prakash, Apurva, Thase, Michael E., Kornstein, Susan G. |
| Source: | Human Psychopharmacology: Clinical & Experimental. Jan2012, Vol. 27 Issue 1, p47-56. 10p. |
| Subjects: | Mental depression, Depressed persons, People with mental illness, Duloxetine, Dopamine uptake inhibitors |
| Abstract: | Objective Return of functional ability is a central goal in the treatment of major depressive disorder. We conducted two trials with the same protocol that was designed to assess functioning after 8 Weeks of treatment with duloxetine. Methods The a priori primary outcome was improvement in the Hamilton Depression Rating Scale (HAMD) item 7 (work/activities). Secondary outcomes included improvement in depressive symptoms assessed by the HAMD Maier subscale, and improvement in functioning assessed by the Sheehan Disability Scale (SDS), and the Social Adaptation Self-evaluation Scale (SASS). Patients were randomly assigned to duloxetine 60 mg/day (Trial I, n = 257; Trial II, n = 261) or placebo (Trial I, n = 127; Trial II, n = 131). Changes from baseline were analyzed using a mixed-effects model repeated measures approach. Results At Week 8, duloxetine was superior to placebo in improving HAMD work/activities ( p < 0.001) in Trial II, but not Trial I ( p = 0.051), and Maier scores ( p < 0.01) in both trials. At Week 12, duloxetine was superior to placebo on improving SASS scores in both trials, and the SDS in Trial II. Conclusion Treatment with duloxetine was associated with significant improvement in depressive symptoms compared with placebo, but improvement in HAMD work/activities was inconsistent at 8 weeks. Copyright © 2012 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR] |
| Copyright of Human Psychopharmacology: Clinical & Experimental is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
| FullText | Links: – Type: pdflink Text: Availability: 0 |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 70602509 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Assessment of depressive symptoms and functional outcomes in patients with major depressive disorder treated with duloxetine versus placebo: primary outcomes from two trials conducted under the same protocol. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Oakes%2C+Tina+Marie+Myers%22">Oakes, Tina Marie Myers</searchLink><br /><searchLink fieldCode="AR" term="%22Myers%2C+Adam+L%2E%22">Myers, Adam L.</searchLink><br /><searchLink fieldCode="AR" term="%22Marangell%2C+Lauren+B%2E%22">Marangell, Lauren B.</searchLink><br /><searchLink fieldCode="AR" term="%22Ahl%2C+Jonna%22">Ahl, Jonna</searchLink><br /><searchLink fieldCode="AR" term="%22Prakash%2C+Apurva%22">Prakash, Apurva</searchLink><br /><searchLink fieldCode="AR" term="%22Thase%2C+Michael+E%2E%22">Thase, Michael E.</searchLink><br /><searchLink fieldCode="AR" term="%22Kornstein%2C+Susan+G%2E%22">Kornstein, Susan G.</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Human+Psychopharmacology%3A+Clinical+%26+Experimental%22">Human Psychopharmacology: Clinical & Experimental</searchLink>. Jan2012, Vol. 27 Issue 1, p47-56. 10p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Mental+depression%22">Mental depression</searchLink><br /><searchLink fieldCode="DE" term="%22Depressed+persons%22">Depressed persons</searchLink><br /><searchLink fieldCode="DE" term="%22People+with+mental+illness%22">People with mental illness</searchLink><br /><searchLink fieldCode="DE" term="%22Duloxetine%22">Duloxetine</searchLink><br /><searchLink fieldCode="DE" term="%22Dopamine+uptake+inhibitors%22">Dopamine uptake inhibitors</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Objective Return of functional ability is a central goal in the treatment of major depressive disorder. We conducted two trials with the same protocol that was designed to assess functioning after 8 Weeks of treatment with duloxetine. Methods The a priori primary outcome was improvement in the Hamilton Depression Rating Scale (HAMD) item 7 (work/activities). Secondary outcomes included improvement in depressive symptoms assessed by the HAMD Maier subscale, and improvement in functioning assessed by the Sheehan Disability Scale (SDS), and the Social Adaptation Self-evaluation Scale (SASS). Patients were randomly assigned to duloxetine 60 mg/day (Trial I, n = 257; Trial II, n = 261) or placebo (Trial I, n = 127; Trial II, n = 131). Changes from baseline were analyzed using a mixed-effects model repeated measures approach. Results At Week 8, duloxetine was superior to placebo in improving HAMD work/activities ( p < 0.001) in Trial II, but not Trial I ( p = 0.051), and Maier scores ( p < 0.01) in both trials. At Week 12, duloxetine was superior to placebo on improving SASS scores in both trials, and the SDS in Trial II. Conclusion Treatment with duloxetine was associated with significant improvement in depressive symptoms compared with placebo, but improvement in HAMD work/activities was inconsistent at 8 weeks. Copyright © 2012 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Human Psychopharmacology: Clinical & Experimental is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1002/hup.1262 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 10 StartPage: 47 Subjects: – SubjectFull: Mental depression Type: general – SubjectFull: Depressed persons Type: general – SubjectFull: People with mental illness Type: general – SubjectFull: Duloxetine Type: general – SubjectFull: Dopamine uptake inhibitors Type: general Titles: – TitleFull: Assessment of depressive symptoms and functional outcomes in patients with major depressive disorder treated with duloxetine versus placebo: primary outcomes from two trials conducted under the same protocol. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Oakes, Tina Marie Myers – PersonEntity: Name: NameFull: Myers, Adam L. – PersonEntity: Name: NameFull: Marangell, Lauren B. – PersonEntity: Name: NameFull: Ahl, Jonna – PersonEntity: Name: NameFull: Prakash, Apurva – PersonEntity: Name: NameFull: Thase, Michael E. – PersonEntity: Name: NameFull: Kornstein, Susan G. IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 01 Text: Jan2012 Type: published Y: 2012 Identifiers: – Type: issn-print Value: 08856222 Numbering: – Type: volume Value: 27 – Type: issue Value: 1 Titles: – TitleFull: Human Psychopharmacology: Clinical & Experimental Type: main |
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