Efficacy and safety of generic escitalopram versus Lexapro in the treatment of major depression: a multicenter double-blinded randomized controlled trial.

BACKGROUND: Depression is an increasingly important public health problem in China, but only a small minority of patients with this condition receive treatment. One of the reasons for low treatment rates is the relatively high cost of imported antidepressant medications.

AIM: Compare the efficacy and safety of the generic form of the selective serotonin re-uptake inhibitory (SSRI) antidepressant escitalopram to the proprietary form of escitalopram (Lexapro) in the treatment of major depression.

METHODS: A multicenter double-blinded randomized controlled trial enrolled 260 patients with depression and randomly assigned them to receive eight weeks of treatment with either generic escitalopram (n=130) or Lexapro (n=130). Efficacy was assessed by the Hamilton rating scale for depression (HAMD-17). Safety was assessed by evaluating adverse events reported by patients, regularly recording vital signs, and conducting laboratory tests and electrocardiograms.

RESULTS: There were 35 (27%) dropouts during the 8 weeks of treatment in the generic escitalopram group and 32 (25%) in the Lexapro group. In the intention-to-treat analysis (i.e., including all patients) the mean (s.d.) drop in the HAMD total score at the end of the 8th week of treatment was 13.9 (8.2) in the generic escitalopram group and 14.3 (8.1) in the Lexapro group (t=0.44, p=0.664). The proportions of patients responsive to treatment (i.e., >50% drop in total HAMD score) were 69% and 67% in the generic escitalopram group and Lexapro group, respectively (χ (2)=0.16, df=1, p=0.690; and the proportions that achieved remission (i.e., final HAMD <7) were 51% and 49% (χ (2)=0.06, df=1, p=0.804). The most frequently reported adverse events were dry mouth (12.3%), nausea (9.2 %) and dizziness (6.2%) in the generic escitalopram group and nausea (10.8%), fainting (7.7%) and drowsiness (6.9%) in the Lexapro group. During the first 35 days of treatment, one suicide and two suicide attempts occurred in the generic escitalopram group and one suicide occurred in the Lexapro group (Fisher exact test, p=0.314).

CONCLUSION: Generic escitalopram is as effective and safe as Lexapro in the initial treatment of patients with moderate to severe episodes of major depression who seek treatment in the outpatient departments of psychiatric hospitals in China. Careful monitoring of the risk of suicidal events is an essential component of the treatment of depressed patients.

TRIAL REGISTRATION: NCT00866593 (clinical.trails.gov).