ArticleShanghai archives of psychiatry2013
Efficacy and safety of generic escitalopram versus Lexapro in the treatment of major depression: a multicenter double-blinded randomized controlled trial.
Article in Shanghai archives of psychiatry, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00866593 (A Randomized Double-blind Parallel Innovator-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram Oxalate Tablets in the Treatment of Chinese Patients With Depression), which is not on this map. Cited by 3 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Double-blind Parallel Innovator-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram Oxalate Tablets in the Treatment of Chinese Patients With Depression
Who cites it
3 citing papers in PubMed, 4 citations in OpenAlex.
- Article
- Long-term bicycle riding ameliorates the depression of the patients undergoing hemodialysis by affecting the levels of interleukin-6 and interleukin-18.Neuropsychiatric disease and treatment · 2017Article
- Efficacy and safety of generic escitalopram (Lexacure(®)) in patients with major depressive disorder: a 6-week multicenter, randomized, rater-blinded, escitalopram-comparative, non-inferiority study.Neuropsychiatric disease and treatment · 2015Article
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Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDepression 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.
aimCompare 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.
methodsA 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.
resultsThere 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).
conclusionGeneric 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 registrationNCT00866593 (clinical.trails.gov).
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