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Psych Congress  

Measures of Suicidality in Phase 3 Clinical Trials of Levomilnacipran ER in Adults with Major Depressive Disorder

Rocsanna Namdar, PharmD
Carl Gommel, MS
Changzheng Chen, PhD
Forest Laboratories, LLC, an affiliate of Actavis, Inc.

Introduction: Changes in suicidal ideation and behavior, as measured by the Columbia Suicide Severity Rating Scale (C-SSRS), were analyzed post hoc using data from four Phase 3 studies of levomilnacipran extended-release (ER) in adults with major depressive disorder MDD. Methods: Patients received levomilnacipran ER (40-120 mg/d) or placebo for 8 weeks. The following analyses were conducted in 2021 patients from the overall Safety Population (N=2066) who had available baseline and ≥1 post-baseline C-SSRS assessments: no suicidal ideation or behavior (score=0) at baseline and during double-blind treatment; score of 0 to 3 at baseline changing to score of 4 or 5 at any time during treatment (treatment-emergent serious suicidal ideation); and score of 0 at baseline changing to score 4 or 5 at any time during treatment (emergence of serious suicidal ideation). Results: Overall, the incidence of any C-SSRS suicidal ideation was similar between placebo and levomilnacipran ER (22.2% and 23.9%, respectively). The incidence of any C-SSRS suicidal behavior was <0.5% in both groups. Shift analyses showed that most patients with baseline C-SSRS score=0 continued to have no suicidal ideation or behavior throughout treatment (placebo, 91.2%; levomilnacipran ER, 88.9%). Results were similar between treatment groups for treatment-emergent serious suicidal ideation (placebo, 1.2%; levomilnacipran ER, 1.0%) and emergence of serious suicidal ideation (both groups, 0.3%). No completed suicides were reported. Conclusions: These results suggest that levomilnacipran ER treatment was not associated with an increased risk of suicidal ideation or behavior relative to placebo in adults with MDD.

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