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Symptomatic and functional improvement in employed depressed patients : a double-blind clinical trial of desvenlafaxine versus placebo . 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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Intervention_Pharmacological
desvenlafaxine
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Intervention_Control
placebo
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Intervention_Pharmacological
desvenlafaxine
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Intervention_Pharmacological
desvenlafaxine succinate
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Outcome_Mental
depressive symptoms and functioning
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Participant_Condition
depressed
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Participant_Condition
major depressive disorder ( MDD )