Abstract | OBJECTIVE: METHODS: Gainfully employed (≥20 h/wk) male and female outpatients with MDD were randomly assigned (2:1 ratio) to 12 weeks of double-blind treatment with desvenlafaxine 50 mg/d or placebo. Analysis of covariance was used to compare differences in week 12 adjusted mean changes from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D₁₇) (primary outcome) and Sheehan Disability Scale (SDS) (key secondary outcome) in the intent-to-treat (ITT) population. A predefined, modified ITT population (ie, those in the ITT population with baseline HAM-D₁₇ ≥20) was also analyzed. Tolerability was assessed by recording adverse events and change on the Arizona Sexual Experience Scale. RESULTS: Baseline HAM-D₁₇ scores for desvenlafaxine (n = 285) and placebo (n = 142) were 22.0 and 21.8, whereas baseline SDS scores were 19.8 and 20.4. Adjusted mean differences between desvenlafaxine and placebo were 2.1 (95% confidence interval [CI], 0.78-3.46; P = 0.002) on the HAM-D₁₇ and 1.3 (95% CI, -0.09 to 2.76; P = 0.067) on the SDS. For the modified ITT sample, desvenlafaxine (n = 208) and placebo (n = 102), baseline HAM-D₁₇ scores were 23.8 and 23.9; the SDS baseline scores were 20.1 and 20.8. Mean differences were 2.6 (95% CI, 0.93-4.22; P = 0.002) on the HAM-D₁₇ and 2.1 (95% CI, 0.36-3.76; P = 0.017) on the SDS. Adverse events and Arizona Sexual Experience Scale scores were comparable between groups. CONCLUSIONS:
Desvenlafaxine 50 mg/d was efficacious for treating MDD in gainfully employed adults. Between-group differences on the SDS narrowly missed statistical significance in the ITT population alone, but the totality of data suggests functional improvements with active treatment.
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Authors | Boadie W Dunlop, Sujana Reddy, Lingfeng Yang, Shannon Lubaczewski, Kristen Focht, Christine J Guico-Pabia |
Journal | Journal of clinical psychopharmacology
(J Clin Psychopharmacol)
Vol. 31
Issue 5
Pg. 569-76
(Oct 2011)
ISSN: 1533-712X [Electronic] United States |
PMID | 21869698
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antidepressive Agents
- Cyclohexanols
- Desvenlafaxine Succinate
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Topics |
- Adult
- Analysis of Variance
- Antidepressive Agents
(adverse effects, therapeutic use)
- Cyclohexanols
(adverse effects, therapeutic use)
- Depressive Disorder, Major
(drug therapy, physiopathology)
- Desvenlafaxine Succinate
- Double-Blind Method
- Employment
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Outpatients
- Prospective Studies
- Psychiatric Status Rating Scales
- Treatment Outcome
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