Symptomatic and Functional Improvement in Employed Depressed Patients

Aug 27, 2011Journal of clinical psychopharmacology

Desvenlafaxine's effects on symptoms and work function in employed depressed patients compared to placebo

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Abstract

Desvenlafaxine 50 mg/d led to an adjusted mean difference of 2.1 points on the Hamilton Depression Rating Scale compared to placebo.

Patients receiving desvenlafaxine showed a significant improvement in depressive symptoms as measured by the Hamilton Depression Rating Scale.
The adjusted mean difference on the Sheehan Disability Scale was 1.3 points for the overall population, which was not statistically significant.
In a modified group with higher baseline depression scores, desvenlafaxine demonstrated a mean difference of 2.6 points on the Hamilton scale and 2.1 points on the Disability scale, both statistically significant.
Adverse events were similar between the desvenlafaxine and placebo groups, indicating comparable tolerability.
Overall, data suggests that desvenlafaxine may improve functioning in employed adults with major depressive disorder.

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OBJECTIVE: This is the first study to assess the efficacy of desvenlafaxine (administered as desvenlafaxine succinate) for improving depressive symptoms and functioning exclusively in employed patients with major depressive disorder (MDD).

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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Symptomatic and Functional Improvement in Employed Depressed Patients

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