Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder

Abstract

ClinicalTrials.gov identifiers: NCT00969709, NCT01377194, NCT00969150, and NCT01034462 and EudraCT identifier: 2006-002404-34.

Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine

“…Patients were randomly assigned to receive placebo or a fixed dose of desvenlafaxine (10,25,50,100,200, or 400 mg) in each study (one study included duloxetine 60 mg/d), and data from placebo and the desvenlafaxine 50-and 100-mg/d treatment arms were included in the analysis. The studies were similar in design; however, six studies were 8 weeks in duration, one was 10 weeks in duration with a week 8 primary endpoint, and one lasted 12 weeks.…”

“…categorical approach to assess changes in function, however, might provide additional information on how individual patients' functioning evolved over time. 25 By examining shifts from marked/extreme impairment to moderate/no impairment versus mild/no impairment after 8 weeks of treatment, we addressed questions that are often raised in clinical practice regarding expectations for antidepressant treatment: How likely is a depressed patient with marked/ extreme impairment at baseline to show some improvement to moderate impairment or better over the course of short-term treatment with antidepressants? Would it be realistic to target mild/no impairment after 8 weeks of treatment?…”

“…In an analysis with another serotonin-norepinephrine reuptake inhibitor antidepressant (levomilnacipran compared with placebo), a greater percentage of patients with MDD shifted from moderate/extreme or marked/extreme impairment at baseline to mild/no impairment, and from marked/extreme impairment to moderate/ no impairment at study endpoint (week 8 or 10) on each SDS subscale and for SDS total score. 25 Clinical guidelines for the management of depression emphasize the importance of monitoring response to treatment in the first weeks in order to make critical optimizations or adjustments (when appropriate and needed) as rapidly as possible. 13,14 There is a growing body of research examining the value of measuring early improvement in depression symptoms to predict clinical efficacy outcomes.…”

“…19 Both mean changes in SDS scores and functional remission rates based on the SDS have been employed to determine the effects of antidepressant treatment on functional impairment associated with depression in clinical trials. [20][21][22][23][24] Cutler and colleagues 25 have suggested that examining categorical shifts in improvement on the SDS (rather than simply assessing changes in mean scores) can be useful in assessing clinically meaningful functional improvement in patients treated for depression. Using pooled data from clinical trials of levomilnacipran for the treatment of MDD, they examined proportions of patients who shifted from more severe to less severe categories of functional impairment after 8 or 10 weeks of antidepressant treatment.…”

“…Using pooled data from clinical trials of levomilnacipran for the treatment of MDD, they examined proportions of patients who shifted from more severe to less severe categories of functional impairment after 8 or 10 weeks of antidepressant treatment. 25 When determined early in treatment, categorical shifts based on the SDS might also allow clinicians to better monitor patient progress over time.…”