A randomized, double-blind, 6-week prospective pilot study on the efficacy and safety of dose escalation in non-remitters in comparison to those of the standard dose of escitalopram for major depressive disorder

Eun Young Kim, Se Hyun Kim, Hyun Jeong Lee, Nam Young Lee, Hye Young Kim, C. Hyung Keun Park, Yong Min Ahn

Research output: Contribution to journalArticle

Abstract

Background: Escalating doses of selective serotonin reuptake inhibitors are often used to treat patients with a suboptimal response to the standard dose. This study assessed the efficacy and safety of dose escalation of escitalopram, up to 30 mg, in non-remitters with major depressive disorder (MDD) after treatment with the standard dose. Method: We recruited 98 patients with MDD (aged 18–65 years). After 4 weeks of open-label treatment with 10–20 mg of escitalopram per day, non-remitters [Montgomery–Åsberg Depression Rating Scale (MADRS) score > 10] were randomized 1:1 for double-blind treatment with either escitalopram (30 mg per day) or escitalopram (20 mg per day) plus placebo for 6 weeks. The primary efficacy outcome was a change in the total MADRS score. Results: After 4 weeks of open-label treatment, 12 patients achieved remission, and 36 dropped out, leaving 50 non-remitters, of whom 44 (88%) completed the double-blind study. The primary outcome measure, the least-squares mean (standard error) change in the total MADRS score at week 6 was significantly different (p = 0.046) between the groups [−8.0 (1.2) in the placebo dose-escalation and −11.8 (1.2) in the escitalopram dose-escalation]. The dose escalation of escitalopram was well tolerated. However, the response and remission rates and quality of life showed no significant differences. Limitations: Small sample size and short follow-up period Conclusion: This study suggests that dose escalation of escitalopram up to 30 mg per day may be beneficial for the treatment of depressive symptoms in non-remitters after standard (10–20 mg/day) treatment.

Original languageEnglish
Pages (from-to)91-97
Number of pages7
JournalJournal of Affective Disorders
Volume259
DOIs
StatePublished - 1 Dec 2019

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Citalopram
Major Depressive Disorder
Prospective Studies
Safety
Therapeutics
Placebos
Depression
Serotonin Uptake Inhibitors
Least-Squares Analysis
Double-Blind Method
Sample Size
Quality of Life
Outcome Assessment (Health Care)

Keywords

  • Dose escalation
  • Escitalopram
  • Major depressive disorder
  • Non-remitter
  • Randomized controlled trial

Cite this

@article{ca7d95c662074a30a53d0654a4c9a826,
title = "A randomized, double-blind, 6-week prospective pilot study on the efficacy and safety of dose escalation in non-remitters in comparison to those of the standard dose of escitalopram for major depressive disorder",
abstract = "Background: Escalating doses of selective serotonin reuptake inhibitors are often used to treat patients with a suboptimal response to the standard dose. This study assessed the efficacy and safety of dose escalation of escitalopram, up to 30 mg, in non-remitters with major depressive disorder (MDD) after treatment with the standard dose. Method: We recruited 98 patients with MDD (aged 18–65 years). After 4 weeks of open-label treatment with 10–20 mg of escitalopram per day, non-remitters [Montgomery–{\AA}sberg Depression Rating Scale (MADRS) score > 10] were randomized 1:1 for double-blind treatment with either escitalopram (30 mg per day) or escitalopram (20 mg per day) plus placebo for 6 weeks. The primary efficacy outcome was a change in the total MADRS score. Results: After 4 weeks of open-label treatment, 12 patients achieved remission, and 36 dropped out, leaving 50 non-remitters, of whom 44 (88{\%}) completed the double-blind study. The primary outcome measure, the least-squares mean (standard error) change in the total MADRS score at week 6 was significantly different (p = 0.046) between the groups [−8.0 (1.2) in the placebo dose-escalation and −11.8 (1.2) in the escitalopram dose-escalation]. The dose escalation of escitalopram was well tolerated. However, the response and remission rates and quality of life showed no significant differences. Limitations: Small sample size and short follow-up period Conclusion: This study suggests that dose escalation of escitalopram up to 30 mg per day may be beneficial for the treatment of depressive symptoms in non-remitters after standard (10–20 mg/day) treatment.",
keywords = "Dose escalation, Escitalopram, Major depressive disorder, Non-remitter, Randomized controlled trial",
author = "Kim, {Eun Young} and Kim, {Se Hyun} and Lee, {Hyun Jeong} and Lee, {Nam Young} and Kim, {Hye Young} and Park, {C. Hyung Keun} and Ahn, {Yong Min}",
year = "2019",
month = "12",
day = "1",
doi = "10.1016/j.jad.2019.08.057",
language = "English",
volume = "259",
pages = "91--97",
journal = "Journal of Affective Disorders",
issn = "0165-0327",
publisher = "Elsevier",

}

TY - JOUR

T1 - A randomized, double-blind, 6-week prospective pilot study on the efficacy and safety of dose escalation in non-remitters in comparison to those of the standard dose of escitalopram for major depressive disorder

AU - Kim, Eun Young

AU - Kim, Se Hyun

AU - Lee, Hyun Jeong

AU - Lee, Nam Young

AU - Kim, Hye Young

AU - Park, C. Hyung Keun

AU - Ahn, Yong Min

PY - 2019/12/1

Y1 - 2019/12/1

N2 - Background: Escalating doses of selective serotonin reuptake inhibitors are often used to treat patients with a suboptimal response to the standard dose. This study assessed the efficacy and safety of dose escalation of escitalopram, up to 30 mg, in non-remitters with major depressive disorder (MDD) after treatment with the standard dose. Method: We recruited 98 patients with MDD (aged 18–65 years). After 4 weeks of open-label treatment with 10–20 mg of escitalopram per day, non-remitters [Montgomery–Åsberg Depression Rating Scale (MADRS) score > 10] were randomized 1:1 for double-blind treatment with either escitalopram (30 mg per day) or escitalopram (20 mg per day) plus placebo for 6 weeks. The primary efficacy outcome was a change in the total MADRS score. Results: After 4 weeks of open-label treatment, 12 patients achieved remission, and 36 dropped out, leaving 50 non-remitters, of whom 44 (88%) completed the double-blind study. The primary outcome measure, the least-squares mean (standard error) change in the total MADRS score at week 6 was significantly different (p = 0.046) between the groups [−8.0 (1.2) in the placebo dose-escalation and −11.8 (1.2) in the escitalopram dose-escalation]. The dose escalation of escitalopram was well tolerated. However, the response and remission rates and quality of life showed no significant differences. Limitations: Small sample size and short follow-up period Conclusion: This study suggests that dose escalation of escitalopram up to 30 mg per day may be beneficial for the treatment of depressive symptoms in non-remitters after standard (10–20 mg/day) treatment.

AB - Background: Escalating doses of selective serotonin reuptake inhibitors are often used to treat patients with a suboptimal response to the standard dose. This study assessed the efficacy and safety of dose escalation of escitalopram, up to 30 mg, in non-remitters with major depressive disorder (MDD) after treatment with the standard dose. Method: We recruited 98 patients with MDD (aged 18–65 years). After 4 weeks of open-label treatment with 10–20 mg of escitalopram per day, non-remitters [Montgomery–Åsberg Depression Rating Scale (MADRS) score > 10] were randomized 1:1 for double-blind treatment with either escitalopram (30 mg per day) or escitalopram (20 mg per day) plus placebo for 6 weeks. The primary efficacy outcome was a change in the total MADRS score. Results: After 4 weeks of open-label treatment, 12 patients achieved remission, and 36 dropped out, leaving 50 non-remitters, of whom 44 (88%) completed the double-blind study. The primary outcome measure, the least-squares mean (standard error) change in the total MADRS score at week 6 was significantly different (p = 0.046) between the groups [−8.0 (1.2) in the placebo dose-escalation and −11.8 (1.2) in the escitalopram dose-escalation]. The dose escalation of escitalopram was well tolerated. However, the response and remission rates and quality of life showed no significant differences. Limitations: Small sample size and short follow-up period Conclusion: This study suggests that dose escalation of escitalopram up to 30 mg per day may be beneficial for the treatment of depressive symptoms in non-remitters after standard (10–20 mg/day) treatment.

KW - Dose escalation

KW - Escitalopram

KW - Major depressive disorder

KW - Non-remitter

KW - Randomized controlled trial

UR - http://www.scopus.com/inward/record.url?scp=85070878367&partnerID=8YFLogxK

U2 - 10.1016/j.jad.2019.08.057

DO - 10.1016/j.jad.2019.08.057

M3 - Article

AN - SCOPUS:85070878367

VL - 259

SP - 91

EP - 97

JO - Journal of Affective Disorders

JF - Journal of Affective Disorders

SN - 0165-0327

ER -