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Psych Congress  

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

Authors  
Rocsanna Namdar, PharmD
Carl Gommel, MS
Changzheng Chen, PhD
Sponsor  
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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