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Baseline patient characteristics associated with placebo remission and their impact on remission with duloxetine and selected SSRI antidepressants

Nelson, J. Craig, Zhang, Qianyi, Kelin, Katarina, Eriksson, Elias, Deberdt, Walter and Berk, Michael 2013, Baseline patient characteristics associated with placebo remission and their impact on remission with duloxetine and selected SSRI antidepressants, Current medical research and opinion, vol. 29, no. 7, pp. 827-833, doi: 10.1185/03007995.2013.795140.

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Title Baseline patient characteristics associated with placebo remission and their impact on remission with duloxetine and selected SSRI antidepressants
Author(s) Nelson, J. Craig
Zhang, Qianyi
Kelin, Katarina
Eriksson, Elias
Deberdt, Walter
Berk, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
Journal name Current medical research and opinion
Volume number 29
Issue number 7
Start page 827
End page 833
Total pages 7
Publisher Taylor & Francis
Place of publication London, Eng.
Publication date 2013-07
ISSN 1473-4877
Keyword(s) Depressive Disorder, Major
Duloxetine Hydrochloride
Humans
Placebo Effect
Placebos
Remission Induction
Serotonin Uptake Inhibitors
Thiophenes
Treatment Outcome
Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
Medicine, Research & Experimental
General & Internal Medicine
Research & Experimental Medicine
Duloxetine
Major depressive disorder (MDD)
Placebo SSRIs
MAJOR DEPRESSIVE DISORDER
PAROXETINE-CONTROLLED TRIAL
DOUBLE-BLIND
NON-INFERIORITY
CLINICAL-TRIAL
ESCITALOPRAM
EFFICACY
ANXIETY
Summary OBJECTIVE: We examined whether identification of patients with placebo-remitter characteristics and placebo-nonremitter characteristics enhances the ability to identify drug-placebo treatment differences and, perhaps, differences between agents in major depressive disorder (MDD). We hypothesized: 1) that drug-placebo differences in remission rates would be greater for both duloxetine and selective serotonin reuptake inhibitors (SSRIs) among placebo nonremitters than placebo remitters and: 2) that the difference between active treatments would also be greater in placebo nonremitters than placebo remitters.

DATA AND METHODS: Data were obtained from seven randomized, parallel, double-blind MDD studies which compared the effects of duloxetine (N = 795), placebo (N = 510), and SSRIs (N = 551). The 17-item Hamilton depression rating scale (HAMD) was used to assess depression severity. The classification of participants as having placebo-remitter or placebo-nonremitter characteristics was based on age, duration of current MDD episode, HAMD anxiety score, and HAMD core score. Odds ratios (ORs) for remission comparing active treatment and placebo were obtained from logistic regression models. Tests of homogeneity were used for between-group comparisons.

RESULTS: For placebo nonremitters, both duloxetine (OR = 3.52 [95% CI: 2.21, 5.62; P < 0.0001]) and SSRIs (OR = 2.38 [95% CI: 1.45, 3.89; P = 0.0006]) showed significantly higher remission rates compared to placebo. Drug-placebo differences in remission were significantly greater for placebo nonremitters than for placebo remitters for both duloxetine (P = 0.02) and SSRIs (P = 0.049). For placebo remitters, remission with duloxetine (OR = 1.83 [95% CI: 1.35, 2.47; P = 0.0001]), but not the SSRIs selected for this study (OR = 1.31 [95% CI: 0.93, 1.84; P = 0.12]), was significantly greater than placebo. Contrary to expectation, the advantage of duloxetine over the SSRIs was not greater in placebo nonremitters. However, the fact that our analysis required patient-level data limited the number of agents studied, compromising generalization.

CONCLUSIONS: Our study suggests that drug-placebo differences in remission rates will be greater in subjects with placebo-nonremitter than with placebo-remitter characteristics.
Language eng
DOI 10.1185/03007995.2013.795140
Field of Research 110319 Psychiatry (incl Psychotherapy)
111714 Mental Health
Socio Economic Objective 920410 Mental Health
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2013, Informa
Persistent URL http://hdl.handle.net/10536/DRO/DU:30067218

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
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