Evidence map›Paper›PMID 26504387›Full record

ArticleNeuropsychiatric disease and treatment2015

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.

Jong-Hyun Jeong, Won-Myong Bahk, Young Sup Woo, Kyung-Uk Lee, Do Hoon Kim, Moon-Doo Kim, Won Kim, Jong-Chul Yang, Kwang Heun Lee

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuropsychiatric disease and treatment, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

The trial behind it

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Jong-Hyun JeongDepartment of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Won-Myong BahkDepartment of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Young Sup WooDepartment of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Kyung-Uk LeeDepartment of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Do Hoon KimDepartment of Psychiatry, Chuncheon Sacred Heart Hospital, Hallym University, Chuncheon, South Korea.
Moon-Doo KimDepartment of Psychiatry, Jeju National University Hospital, Jeju, South Korea.
Won KimDepartment of Psychiatry, Stress Research Institute, Seoul Paik Hospital, College of Medicine, Inje University, Seoul, South Korea.
Jong-Chul YangDepartment of Psychiatry, Chonbuk National University Medical School, Jeonju, South Korea.
Kwang Heun LeeDepartment of Psychiatry, College of Medicine, Dongguk University, Gyeongju, South Korea.
Catholic University of Korea · KRDongguk University · KRJeju National University Hospital · KRJeonbuk National University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe 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).

methodsThe present study included 158 patients, who were randomized (1:1) to receive a flexible dose of generic escitalopram (n=78) or branded escitalopram (n=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.

resultsDuring the 6-week study period, 30 patients (38.5%) from the generic escitalopram group and 28 patients (30.0%) from the branded escitalopram group dropped out of the study (P=0.727). The MADRS, HDRS, CGI-S, and CGI-I scores significantly decreased in both groups, and there were no significant differences between the groups. 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 (as indicated by a ≥50% decrease from the baseline MADRS score; P=0.126), and the remission rates (MADRS score: ≤10) were 42.9% (n=21) in generic escitalopram group and 53.8% (n=28) in the branded escitalopram group (P=0.135). The most frequently reported AEs were nausea (17.9%), sleepiness/somnolence (7.7%), weight gain (3.8%), and dry mouth (2.6%) in the generic escitalopram group and nausea (20.0%), sleepiness/somnolence (3.8%), weight gain (2.5%), and dry mouth (2.5%) in the branded escitalopram group.

conclusionThe present non-inferiority study demonstrated that generic escitalopram is a safe and an effective initial treatment for patients with MDD and may also be considered as an additional therapeutic option for this population.

Indexed as

branded escitalopramdepressiongeneric escitalopramLexacure®Lexapro®

Identifiers

PMID26504387
PMCPMC4605251
OpenAlexW1957941398

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.