Predictors of relapse in patients with major depressive disorder in a 52-week, fixed dose, double blind, randomized trial of selegiline transdermal system (STS)

Saeheon Jang; Sungwon Jung; Chiun Pae; Blanchard Portland Kimberly; J. Craig Nelson; Ashwin A. Patkar

doi:10.1016/j.jad.2013.07.023

Predictors of relapse in patients with major depressive disorder in a 52-week, fixed dose, double blind, randomized trial of selegiline transdermal system (STS)

Saeheon Jang
, Sungwon Jung
, Chiun Pae
, Blanchard Portland Kimberly
, J. Craig Nelson
, Ashwin A. Patkar

Department of Psychiatry

Duke University
Bongseng Memorial Hospital
Keimyung University
Mylan Specialty L.P.
University of California at San Francisco

Research output: Contribution to journal › Article › peer-review

14 Scopus citations

Abstract

Objective We investigated patient and disease characteristics predictive of relapse of MDD during a 52-week placebo controlled trial of selegiline transdermal system (STS) to identify patient characteristics relevant for STS treatment. Method After 10 weeks of open-label stabilization with STS, 322 remitted patients with MDD were randomized to 52-weeks of double-blind treatment with STS (6 mg/24 h) or placebo (PLB). Relapse was defined as Hamilton Depression Rating Scale (HAMD-17) score of ≥14 and a CGI-S score of ≥3 with at least 2-point increase from the beginning of the double blind phase on 2 consecutive visits. Cox's proportional hazards regression was used to examine the effect of potential predictors (age, sex, age at onset of first MDD, early response pattern, number of previous antidepressant trials, severity of index episode, number of previous episodes, melancholic features, atypical features and anxious feature) on outcome. Exploratory analyses examined additional clinical variables (medical history, other psychiatric history, and individual items of HAM-D 28) on relapse. Results For all predictor variables analyzed, treatment Hazard Ratio (HR=0.48~0.54) was significantly in favor of STS (i.e.; lower relapse risk than PLB). Age of onset was significantly predictive of relapse. Type, duration, and severity of depressive episodes, previous antidepressant trials, or demographic variables did not predict relapse. In additional exploratory analysis, eating disorder history and suicidal ideation were significant predictors of relapse after controlling for the effect of treatment in individual predictor analysis. Conclusions While age of onset, eating disorder history and suicidal ideation were significant predictors, the majority of clinical and demographic variables were not predictive of relapse. Given the post-hoc nature of analysis, the findings need confirmation from a prospective study. It appears that selegiline transdermal system was broadly effective in preventing relapse across different subtypes and symptoms clusters of MDD.

Original language	English
Pages (from-to)	854-859
Number of pages	6
Journal	Journal of Affective Disorders
Volume	151
Issue number	3
DOIs	https://doi.org/10.1016/j.jad.2013.07.023
State	Published - Dec 2013

Bibliographical note

Funding Information:
Dr. Portland is an employee of Mylan Specialty L.P. and may hold stock and/or stock options in Mylan. Dr. Jang has received grant/support from Janssen, Lundbeck and Otsuka; has served as a speaker for Janssen, Sanofi-Aventis, AstraZeneca, GlaxoSmithkline and Eli Lilly. Dr. Jung has nothing to disclose. Dr. Jae has received grant support from Janssen; has served as a speaker for Eli Lilly, GlaxoSmithkline, Pfizer, Janssen, Otsuka, AstraZeneca and Sanofi-Aventis. Dr. Pae has received research grants from GlaxoSmithKline Korea, GlaxoSmithKline, AstraZeneca Korea, Janssen Pharmaceuticals Korea, Eli Lilly Korea, KHIDI, Otsuka Korea, Wyeth Korea, Ministry of Health and Welfare, Korea Research Foundation, and Korean Institute of Science and Technology Evaluation and Planning; has received honoraria from and is on the speakers bureaus of GlaxoSmithKline Korea, Pfizer Korea, Lundbeck Korea, Sandoz Korea, AstraZeneca Korea, Jeil Pharmaceuticals, Eisai Korea, Janssen Korea, Eli Lilly Korea, and Otsuka Korea; and has stock holdings in Dongwha Pharmaceuticals. Dr. Nelson has served as an advisor or consultant for Avanir, Bristol-Myers Squibb, Cenestra Health, Corcept, Mylan Specialty L.P., Eli Lilly, Forest, Labopharm, Lundbeck, Medtronic, Merck, Otsuka, Pfizer, and Sunovion; received lecture honoraria from Eli Lilly Global, Lundbeck, Otsuka Asia, Merck Asia; received research support from NIMH and HRSA; and owns stock in Atossa.Dr. Patkar is a consultant for and/or on the advisory boards of Bristol-Myers Squibb, GlaxoSmithKline, Mylan Specialty L.P., Pfizer, and Reckitt Benckiser; has received honoraria and is on the speaker's bureaus of Bristol-Myers Squibb, GlaxoSmithKline, Mylan Specialty L.P., and Reckitt Benckiser; and has received research support from AstraZeneca, Bristol-Myers Squibb, Forest, GlaxoSmithKline, Janssen, McNeil Consumer and Mylan Specialty L.P., the National Institutes of Health, Organon, Jazz Pharmaceuticals, and Pfizer.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Antidepressant
Depression
Relapse
Selegiline transdermal system

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10.1016/j.jad.2013.07.023

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@article{c3f23dea2b23478a9833955b0fca5ac3,

title = "Predictors of relapse in patients with major depressive disorder in a 52-week, fixed dose, double blind, randomized trial of selegiline transdermal system (STS)",

abstract = "Objective We investigated patient and disease characteristics predictive of relapse of MDD during a 52-week placebo controlled trial of selegiline transdermal system (STS) to identify patient characteristics relevant for STS treatment. Method After 10 weeks of open-label stabilization with STS, 322 remitted patients with MDD were randomized to 52-weeks of double-blind treatment with STS (6 mg/24 h) or placebo (PLB). Relapse was defined as Hamilton Depression Rating Scale (HAMD-17) score of ≥14 and a CGI-S score of ≥3 with at least 2-point increase from the beginning of the double blind phase on 2 consecutive visits. Cox's proportional hazards regression was used to examine the effect of potential predictors (age, sex, age at onset of first MDD, early response pattern, number of previous antidepressant trials, severity of index episode, number of previous episodes, melancholic features, atypical features and anxious feature) on outcome. Exploratory analyses examined additional clinical variables (medical history, other psychiatric history, and individual items of HAM-D 28) on relapse. Results For all predictor variables analyzed, treatment Hazard Ratio (HR=0.48\textasciitilde{}0.54) was significantly in favor of STS (i.e.; lower relapse risk than PLB). Age of onset was significantly predictive of relapse. Type, duration, and severity of depressive episodes, previous antidepressant trials, or demographic variables did not predict relapse. In additional exploratory analysis, eating disorder history and suicidal ideation were significant predictors of relapse after controlling for the effect of treatment in individual predictor analysis. Conclusions While age of onset, eating disorder history and suicidal ideation were significant predictors, the majority of clinical and demographic variables were not predictive of relapse. Given the post-hoc nature of analysis, the findings need confirmation from a prospective study. It appears that selegiline transdermal system was broadly effective in preventing relapse across different subtypes and symptoms clusters of MDD.",

keywords = "Antidepressant, Depression, Relapse, Selegiline transdermal system",

author = "Saeheon Jang and Sungwon Jung and Chiun Pae and Kimberly, \{Blanchard Portland\} and \{Craig Nelson\}, J. and Patkar, \{Ashwin A.\}",

note = "Funding Information: Dr. Portland is an employee of Mylan Specialty L.P. and may hold stock and/or stock options in Mylan. Dr. Jang has received grant/support from Janssen, Lundbeck and Otsuka; has served as a speaker for Janssen, Sanofi-Aventis, AstraZeneca, GlaxoSmithkline and Eli Lilly. Dr. Jung has nothing to disclose. Dr. Jae has received grant support from Janssen; has served as a speaker for Eli Lilly, GlaxoSmithkline, Pfizer, Janssen, Otsuka, AstraZeneca and Sanofi-Aventis. Dr. Pae has received research grants from GlaxoSmithKline Korea, GlaxoSmithKline, AstraZeneca Korea, Janssen Pharmaceuticals Korea, Eli Lilly Korea, KHIDI, Otsuka Korea, Wyeth Korea, Ministry of Health and Welfare, Korea Research Foundation, and Korean Institute of Science and Technology Evaluation and Planning; has received honoraria from and is on the speakers bureaus of GlaxoSmithKline Korea, Pfizer Korea, Lundbeck Korea, Sandoz Korea, AstraZeneca Korea, Jeil Pharmaceuticals, Eisai Korea, Janssen Korea, Eli Lilly Korea, and Otsuka Korea; and has stock holdings in Dongwha Pharmaceuticals. Dr. Nelson has served as an advisor or consultant for Avanir, Bristol-Myers Squibb, Cenestra Health, Corcept, Mylan Specialty L.P., Eli Lilly, Forest, Labopharm, Lundbeck, Medtronic, Merck, Otsuka, Pfizer, and Sunovion; received lecture honoraria from Eli Lilly Global, Lundbeck, Otsuka Asia, Merck Asia; received research support from NIMH and HRSA; and owns stock in Atossa.Dr. Patkar is a consultant for and/or on the advisory boards of Bristol-Myers Squibb, GlaxoSmithKline, Mylan Specialty L.P., Pfizer, and Reckitt Benckiser; has received honoraria and is on the speaker's bureaus of Bristol-Myers Squibb, GlaxoSmithKline, Mylan Specialty L.P., and Reckitt Benckiser; and has received research support from AstraZeneca, Bristol-Myers Squibb, Forest, GlaxoSmithKline, Janssen, McNeil Consumer and Mylan Specialty L.P., the National Institutes of Health, Organon, Jazz Pharmaceuticals, and Pfizer. ",

year = "2013",

month = dec,

doi = "10.1016/j.jad.2013.07.023",

language = "English",

volume = "151",

pages = "854--859",

journal = "Journal of Affective Disorders",

issn = "0165-0327",

publisher = "Elsevier B.V.",

number = "3",

}

TY - JOUR

T1 - Predictors of relapse in patients with major depressive disorder in a 52-week, fixed dose, double blind, randomized trial of selegiline transdermal system (STS)

AU - Jang, Saeheon

AU - Jung, Sungwon

AU - Pae, Chiun

AU - Kimberly, Blanchard Portland

AU - Craig Nelson, J.

AU - Patkar, Ashwin A.

N1 - Funding Information: Dr. Portland is an employee of Mylan Specialty L.P. and may hold stock and/or stock options in Mylan. Dr. Jang has received grant/support from Janssen, Lundbeck and Otsuka; has served as a speaker for Janssen, Sanofi-Aventis, AstraZeneca, GlaxoSmithkline and Eli Lilly. Dr. Jung has nothing to disclose. Dr. Jae has received grant support from Janssen; has served as a speaker for Eli Lilly, GlaxoSmithkline, Pfizer, Janssen, Otsuka, AstraZeneca and Sanofi-Aventis. Dr. Pae has received research grants from GlaxoSmithKline Korea, GlaxoSmithKline, AstraZeneca Korea, Janssen Pharmaceuticals Korea, Eli Lilly Korea, KHIDI, Otsuka Korea, Wyeth Korea, Ministry of Health and Welfare, Korea Research Foundation, and Korean Institute of Science and Technology Evaluation and Planning; has received honoraria from and is on the speakers bureaus of GlaxoSmithKline Korea, Pfizer Korea, Lundbeck Korea, Sandoz Korea, AstraZeneca Korea, Jeil Pharmaceuticals, Eisai Korea, Janssen Korea, Eli Lilly Korea, and Otsuka Korea; and has stock holdings in Dongwha Pharmaceuticals. Dr. Nelson has served as an advisor or consultant for Avanir, Bristol-Myers Squibb, Cenestra Health, Corcept, Mylan Specialty L.P., Eli Lilly, Forest, Labopharm, Lundbeck, Medtronic, Merck, Otsuka, Pfizer, and Sunovion; received lecture honoraria from Eli Lilly Global, Lundbeck, Otsuka Asia, Merck Asia; received research support from NIMH and HRSA; and owns stock in Atossa.Dr. Patkar is a consultant for and/or on the advisory boards of Bristol-Myers Squibb, GlaxoSmithKline, Mylan Specialty L.P., Pfizer, and Reckitt Benckiser; has received honoraria and is on the speaker's bureaus of Bristol-Myers Squibb, GlaxoSmithKline, Mylan Specialty L.P., and Reckitt Benckiser; and has received research support from AstraZeneca, Bristol-Myers Squibb, Forest, GlaxoSmithKline, Janssen, McNeil Consumer and Mylan Specialty L.P., the National Institutes of Health, Organon, Jazz Pharmaceuticals, and Pfizer.

PY - 2013/12

Y1 - 2013/12

N2 - Objective We investigated patient and disease characteristics predictive of relapse of MDD during a 52-week placebo controlled trial of selegiline transdermal system (STS) to identify patient characteristics relevant for STS treatment. Method After 10 weeks of open-label stabilization with STS, 322 remitted patients with MDD were randomized to 52-weeks of double-blind treatment with STS (6 mg/24 h) or placebo (PLB). Relapse was defined as Hamilton Depression Rating Scale (HAMD-17) score of ≥14 and a CGI-S score of ≥3 with at least 2-point increase from the beginning of the double blind phase on 2 consecutive visits. Cox's proportional hazards regression was used to examine the effect of potential predictors (age, sex, age at onset of first MDD, early response pattern, number of previous antidepressant trials, severity of index episode, number of previous episodes, melancholic features, atypical features and anxious feature) on outcome. Exploratory analyses examined additional clinical variables (medical history, other psychiatric history, and individual items of HAM-D 28) on relapse. Results For all predictor variables analyzed, treatment Hazard Ratio (HR=0.48~0.54) was significantly in favor of STS (i.e.; lower relapse risk than PLB). Age of onset was significantly predictive of relapse. Type, duration, and severity of depressive episodes, previous antidepressant trials, or demographic variables did not predict relapse. In additional exploratory analysis, eating disorder history and suicidal ideation were significant predictors of relapse after controlling for the effect of treatment in individual predictor analysis. Conclusions While age of onset, eating disorder history and suicidal ideation were significant predictors, the majority of clinical and demographic variables were not predictive of relapse. Given the post-hoc nature of analysis, the findings need confirmation from a prospective study. It appears that selegiline transdermal system was broadly effective in preventing relapse across different subtypes and symptoms clusters of MDD.

AB - Objective We investigated patient and disease characteristics predictive of relapse of MDD during a 52-week placebo controlled trial of selegiline transdermal system (STS) to identify patient characteristics relevant for STS treatment. Method After 10 weeks of open-label stabilization with STS, 322 remitted patients with MDD were randomized to 52-weeks of double-blind treatment with STS (6 mg/24 h) or placebo (PLB). Relapse was defined as Hamilton Depression Rating Scale (HAMD-17) score of ≥14 and a CGI-S score of ≥3 with at least 2-point increase from the beginning of the double blind phase on 2 consecutive visits. Cox's proportional hazards regression was used to examine the effect of potential predictors (age, sex, age at onset of first MDD, early response pattern, number of previous antidepressant trials, severity of index episode, number of previous episodes, melancholic features, atypical features and anxious feature) on outcome. Exploratory analyses examined additional clinical variables (medical history, other psychiatric history, and individual items of HAM-D 28) on relapse. Results For all predictor variables analyzed, treatment Hazard Ratio (HR=0.48~0.54) was significantly in favor of STS (i.e.; lower relapse risk than PLB). Age of onset was significantly predictive of relapse. Type, duration, and severity of depressive episodes, previous antidepressant trials, or demographic variables did not predict relapse. In additional exploratory analysis, eating disorder history and suicidal ideation were significant predictors of relapse after controlling for the effect of treatment in individual predictor analysis. Conclusions While age of onset, eating disorder history and suicidal ideation were significant predictors, the majority of clinical and demographic variables were not predictive of relapse. Given the post-hoc nature of analysis, the findings need confirmation from a prospective study. It appears that selegiline transdermal system was broadly effective in preventing relapse across different subtypes and symptoms clusters of MDD.

KW - Antidepressant

KW - Depression

KW - Relapse

KW - Selegiline transdermal system

UR - https://www.scopus.com/pages/publications/84886728828

U2 - 10.1016/j.jad.2013.07.023

DO - 10.1016/j.jad.2013.07.023

M3 - Article

C2 - 24021959

AN - SCOPUS:84886728828

SN - 0165-0327

VL - 151

SP - 854

EP - 859

JO - Journal of Affective Disorders

JF - Journal of Affective Disorders

IS - 3

ER -

Predictors of relapse in patients with major depressive disorder in a 52-week, fixed dose, double blind, randomized trial of selegiline transdermal system (STS)

Abstract

Bibliographical note

UN SDGs

Keywords

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