New Depression Episodes Delayed In People Taking Cymbalta
New data suggest that Cymbalta (duloxetine HCl) 60 mg to 120 mg once daily delayed the onset of a new episode of depression in patients who had previously responded to the medication and who had recurrent depressive disorder, defined in the study as those patients who experienced at least three depressive episodes in the previous five years, compared with placebo (p < .001).
Results from the 52- week maintenance phase of the longest controlled duloxetine study completed to date were presented at a meeting of a major scientific society today.
Additionally, patients who were treated with duloxetine were less likely (p < .001) to experience a new episode of depression than those who received placebo (recurrence rates were 14.4 percent vs. 33.1 percent, respectively).
Previous research has shown that up to 85 percent of patients with depression will experience depressive recurrences.(i) The number of episodes,(ii) their duration(iii) and the presence of lingering depressive symptoms increase the risk of recurrence, or future episodes of depression.(iv)
In the placebo-controlled maintenance phase of the study that followed initial open-label acute and continuation treatment phases, the most common adverse events (those occurring in at least 5 percent of patients in any treatment group) were headache, insomnia, dizziness, fatigue, back pain, common cold and flu.
The 52-week maintenance phase was preceded by up to 34-weeks of open-label treatment with duloxetine 60-120 mg once daily. Of the 514 patients initially entered into the study, 288 patients met response criteria at the end of up to 34 weeks treatment and were entered into the 52-week, double-blind, maintenance phase of the study. During the maintenance phase, patients were randomly assigned to receive either duloxetine at the dose to which they had previously responded, or placebo.
The primary endpoint of the study was time to recurrence of a major depressive episode during 52 weeks of maintenance treatment, as assessed by any of the following recurrence criteria: a CGI-S score greater than or equal to 4 and meeting DSM-IV criteria for major depressive disorder; three consecutive visits meeting re-emergence criteria or 10 total re-emergence visits; or study discontinuation due to lack of efficacy. Secondary measures included the HAMD17 total score and subscales, CGI-S and PGI-I scales, SQ-SS and VAS for pain. Safety and tolerability were assessed via analysis of treatment-emergent adverse events, vital signs, weight, ASEX for sexual functioning and laboratory measures. The primary study manuscript has already been submitted for review with a view to publication in a peer-reviewed medical journal.