{"doi":"10.1016/j.eurpsy.2016.01.560","title":"Efficacy and safety of generic escitalopram (Lexacure) in patients with major depressive disorder: A 6-week, multi-center, randomized, rater-blinded, escitalopram-comparative, non-inferiority study","abstract":"<jats:sec id=\"S0924933800226898_abst0001\" sec-type=\"other\"><jats:title>Objectives</jats:title><jats:p>The primary aim of this non-inferiority study was to investigate the clinical effectiveness and safety of generic escitalopram (Lexacure) versus branded escitalopram (Lexapro) for patients with major depressive disorder (MDD).</jats:p></jats:sec><jats:sec id=\"S0924933800226898_abst0002\" sec-type=\"methods\"><jats:title>Methods</jats:title><jats:p>The present study included 158 patients who were randomized (1:1) to receive a flexible dose of generic escitalopram (<jats:italic>n</jats:italic> = 78) or branded escitalopram (<jats:italic>n</jats:italic> = 80) over a 6-week single-blind treatment period. The clinical benefits in the two groups were evaluated using the Montgomery–Åsberg Depression Rating Scale (MADRS), the 17-item Hamilton Depression Rating Scale (HDRS), the Clinical Global Impressions-Severity Scale (CGI-S), and the Clinical Global Impressions-Improvement Scale (CGI-I) at baseline, week 1, week 2, week 4, and week 6. The frequency of adverse events (AEs) was also assessed to determine safety at each follow-up visit.</jats:p></jats:sec><jats:sec id=\"S0924933800226898_abst0003\" sec-type=\"results\"><jats:title>Results</jats:title><jats:p>At week 6, 28 patients (57.1%) in the generic escitalopram group and 35 patients (67.3%) in the branded escitalopram group had responded to treatment (<jats:italic>P</jats:italic> = 0.126), and the remission rates (MADRS score: ≤ 10) were 42.9% (<jats:italic>n</jats:italic> = 21) in generic escitalopram group and 53.8% (<jats:italic>n</jats:italic> = 28) in the branded escitalopram group (<jats:italic>P</jats:italic> = 0.135). The most frequently reported AEs were nausea (17.9%) in the generic escitalopram group and nausea (20.0%) in the branded escitalopram group.</jats:p></jats:sec><jats:sec id=\"S0924933800226898_abst0004\" sec-type=\"conclusions\"><jats:title>Conclusions</jats:title><jats:p>The present non-inferiority study demonstrated that generic escitalopram is a safe and effective initial treatment for patients with MDD and may also be considered as an additional therapeutic option for this population.</jats:p></jats:sec><jats:sec id=\"S0924933800226898_sec0001\" sec-type=\"other\"><jats:title>Disclosure of interest</jats:title><jats:p>The authors have not supplied their declaration of competing interest.</jats:p></jats:sec>","journal":"European Psychiatry","year":2016,"id":599874,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1537551,"name":"W.M. Bahk","orcid":null,"position":1,"is_corresponding":false},{"id":1537553,"name":"Y.S. Woo","orcid":null,"position":2,"is_corresponding":false},{"id":1537555,"name":"K.U. Lee","orcid":null,"position":3,"is_corresponding":false},{"id":1537557,"name":"M.D. Kim","orcid":null,"position":4,"is_corresponding":false},{"id":992324,"name":"W. Kim","orcid":null,"position":5,"is_corresponding":false},{"id":1537560,"name":"J.C. Yang","orcid":null,"position":6,"is_corresponding":false},{"id":837905,"name":"K.H. Lee","orcid":null,"position":7,"is_corresponding":false},{"id":1537561,"name":"S.Y. Lee","orcid":null,"position":8,"is_corresponding":false},{"id":1537548,"name":"J.H. Jeong","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Efficacy and safety of generic escitalopram (Lexacure) in patients with major depressive disorder: A 6-week, multi-center, randomized, rater-blinded, escitalopram-comparative, non-inferiority study","abstract":"<jats:sec id=\"S0924933800226898_abst0001\" sec-type=\"other\"><jats:title>Objectives</jats:title><jats:p>The primary aim of this non-inferiority study was to investigate the clinical effectiveness and safety of generic escitalopram (Lexacure) versus branded escitalopram (Lexapro) for patients with major depressive disorder (MDD).</jats:p></jats:sec><jats:sec id=\"S0924933800226898_abst0002\" sec-type=\"methods\"><jats:title>Methods</jats:title><jats:p>The present study included 158 patients who were randomized (1:1) to receive a flexible dose of generic escitalopram (<jats:italic>n</jats:italic> = 78) or branded escitalopram (<jats:italic>n</jats:italic> = 80) over a 6-week single-blind treatment period. The clinical benefits in the two groups were evaluated using the Montgomery–Åsberg Depression Rating Scale (MADRS), the 17-item Hamilton Depression Rating Scale (HDRS), the Clinical Global Impressions-Severity Scale (CGI-S), and the Clinical Global Impressions-Improvement Scale (CGI-I) at baseline, week 1, week 2, week 4, and week 6. The frequency of adverse events (AEs) was also assessed to determine safety at each follow-up visit.</jats:p></jats:sec><jats:sec id=\"S0924933800226898_abst0003\" sec-type=\"results\"><jats:title>Results</jats:title><jats:p>At week 6, 28 patients (57.1%) in the generic escitalopram group and 35 patients (67.3%) in the branded escitalopram group had responded to treatment (<jats:italic>P</jats:italic> = 0.126), and the remission rates (MADRS score: ≤ 10) were 42.9% (<jats:italic>n</jats:italic> = 21) in generic escitalopram group and 53.8% (<jats:italic>n</jats:italic> = 28) in the branded escitalopram group (<jats:italic>P</jats:italic> = 0.135). The most frequently reported AEs were nausea (17.9%) in the generic escitalopram group and nausea (20.0%) in the branded escitalopram group.</jats:p></jats:sec><jats:sec id=\"S0924933800226898_abst0004\" sec-type=\"conclusions\"><jats:title>Conclusions</jats:title><jats:p>The present non-inferiority study demonstrated that generic escitalopram is a safe and effective initial treatment for patients with MDD and may also be considered as an additional therapeutic option for this population.</jats:p></jats:sec><jats:sec id=\"S0924933800226898_sec0001\" sec-type=\"other\"><jats:title>Disclosure of interest</jats:title><jats:p>The authors have not supplied their declaration of competing interest.</jats:p></jats:sec>","is_dataset_classified":null,"base_score":0.0,"endowment":0.0,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"21097893","pmcid":null,"openalex_id":"https://openalex.org/W2363929995","authors":[],"funders":[],"total_grants":0,"fwci":null,"citation_percentile":null,"influential_citations":0,"citation_trend":[],"oa_status":"bronze","license":"https://www.cambridge.org/core/terms","oa_locations":[{"url":"https://www.cambridge.org/core/services/aop-cambridge-core/content/view/34226AD7E7544BC29B5FDF42EC0D428A/S0924933800226898a.pdf/div-class-title-efficacy-and-safety-of-generic-escitalopram-lexacure-in-patients-with-major-depressive-disorder-a-6-week-multi-center-randomized-rater-blinded-escitalopram-comparative-non-inferiority-study-div.pdf","host_type":"journal"},{"url":"https://www.cambridge.org/core/services/aop-cambridge-core/content/view/34226AD7E7544BC29B5FDF42EC0D428A/S0924933800226898a.pdf/div-class-title-efficacy-and-safety-of-generic-escitalopram-lexacure-in-patients-with-major-depressive-disorder-a-6-week-multi-center-randomized-rater-blinded-escitalopram-comparative-non-inferiority-study-div.pdf","host_type":"publisher"},{"url":"https://api.elsevier.com/content/article/PII:S0924933816005642?httpAccept=text/xml","host_type":"publisher"},{"url":"https://api.elsevier.com/content/article/PII:S0924933816005642?httpAccept=text/plain","host_type":"publisher"},{"url":"https://www.cambridge.org/core/services/aop-cambridge-core/content/view/S0924933800226898","host_type":"publisher"},{"url":"https://doi.org/10.1016/j.eurpsy.2016.01.560","host_type":"journal"}],"fields_of_study":["Treatment of Major Depression","Pharmaceutical Economics and Policy"],"mesh_terms":[],"keywords":["Escitalopram","Major depressive disorder","Psychology","Nausea","Rating scale","Adverse effect","Depression (economics)","Psychiatry","Hamilton Rating Scale for Depression","Internal medicine","Medicine","Antidepressant","Mood","Anxiety"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-07-29T11:31:02.484256Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}