Assessment of functional outcomes by Sheehan Disability Scale in patients with major depressive disorder treated with duloxetine versus selective serotonin reuptake inhibitors.
OBJECTIVE
We compared functional impairment outcomes assessed with Sheehan Disability Scale (SDS) after treatment with duloxetine versus selective serotonin reuptake inhibitors (SSRIs) in patients with major depressive disorder.


METHODS
Data were pooled from four randomized studies comparing treatment with duloxetine and SSRIs (three double blind and one open label). Analysis of covariance, with last-observation-carried-forward approach for missing data, explored treatment differences between duloxetine and SSRIs on SDS changes during 8 to 12 weeks of acute treatment for the intent-to-treat population. Logistic regression analysis examined the predictive capacity of baseline patient characteristics for remission in functional impairment (SDS total score ≤ 6 and SDS item scores ≤ 2) at endpoint.


RESULTS
Included were 2193 patients (duloxetine n = 1029; SSRIs n = 835; placebo n = 329). Treatment with duloxetine and SSRIs resulted in significantly (p < 0.01) greater improvements in the SDS total score versus treatment with placebo. Higher SDS (p < 0.0001) or 17-item Hamilton Depression Rating Scale baseline scores (p < 0.01) predicted lower probability of functional improvement after treatment with duloxetine or SSRIs. Female gender (p ≤ 0.05) predicted higher probability of functional improvement after treatment with duloxetine or SSRIs.


CONCLUSIONS
Treatment with SSRIs and duloxetine improved functional impairment in patients with major depressive disorder. Higher SDS or 17-item Hamilton Depression Rating Scale baseline scores predicted less probability of SDS improvement; female gender predicted better improvement in functional impairment at endpoint.
Morsani College of Medicine, University of South Florida, Tampa, Florida, USA.
David V
DV
Sheehan
Eli Lilly and Company, Bad Homburg, Germany.
Michele
M
Mancini
Lilly Suzhou Pharmaceutical Company Ltd, Shanghai, China.
Jianing
J
Wang
Eli Lilly and Company, Bad Homburg, Germany.
Lovisa
L
Berggren
Lilly Suzhou Pharmaceutical Company Ltd, Shanghai, China.
Haijun
H
Cao
Lilly Emerging Markets, Mexico City, Mexico.
Héctor José
HJ
Dueñas
Lilly Suzhou Pharmaceutical Company Ltd, Shanghai, China.
Li
L
Yue
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000503:physiopathology; D004185:Disability Evaluation; D000068736:Duloxetine Hydrochloride / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
D000928:Antidepressive Agents; D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors
HAMD-17; MADRS; SDS; SSRIs; duloxetine; remission