Efficacy of antidepressants: bias in randomized clinical trials and related issues

Sheng Min Wang, Changsu Han, Soo Jung Lee, Tae Youn Jun, Ashwin A. Patkar, Prakash S. Masand, Chi Un Pae

Research output: Contribution to journalReview article

6 Citations (Scopus)

Abstract

Introduction: Countless antidepressant randomized trials were conducted and showed statistically significant benefits of selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) over placebo. Meanwhile, critics are increasing regarding the efficacy of antidepressants in the treatment of MDD because at least a proportion of clinical trials could be hampered by various biases. In contrast, number of failed trials is increasing in the recent years which have made developing psychiatric medications progressively more time-consuming and expensive. Areas covered: Biases and related issues in clinical trials for antidepressants can be identified as an important common contributing factor to the two paradoxical phenomenon. This review identifies possible biases that can occur before, during, and after clinical trials of antidepressant. Expert commentary: Recent studies not only may over-estimate efficacy of antidepressants, but also may exaggerate placebo response because of various biases. Sponsorship and publication biases have been one of the targets of the criticism and ethical debate. Thus, initiating new trend of research by re-organizing academic-industry partnership will be the most important task in the next five years.

Original languageEnglish
Pages (from-to)15-25
Number of pages11
JournalExpert Review of Clinical Pharmacology
Volume11
Issue number1
DOIs
Publication statusPublished - 2018 Jan 2

Fingerprint

Antidepressive Agents
Randomized Controlled Trials
Clinical Trials
Placebos
Publication Bias
Serotonin Uptake Inhibitors
Psychiatry
Industry
Research
Therapeutics

Keywords

  • Antidepressant
  • bias
  • clinical trial
  • placebo response
  • review

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Pharmacology (medical)

Cite this

Efficacy of antidepressants : bias in randomized clinical trials and related issues. / Wang, Sheng Min; Han, Changsu; Lee, Soo Jung; Jun, Tae Youn; Patkar, Ashwin A.; Masand, Prakash S.; Pae, Chi Un.

In: Expert Review of Clinical Pharmacology, Vol. 11, No. 1, 02.01.2018, p. 15-25.

Research output: Contribution to journalReview article

Wang, Sheng Min ; Han, Changsu ; Lee, Soo Jung ; Jun, Tae Youn ; Patkar, Ashwin A. ; Masand, Prakash S. ; Pae, Chi Un. / Efficacy of antidepressants : bias in randomized clinical trials and related issues. In: Expert Review of Clinical Pharmacology. 2018 ; Vol. 11, No. 1. pp. 15-25.
@article{76252871bb1b4ca7882ff2599303a4b4,
title = "Efficacy of antidepressants: bias in randomized clinical trials and related issues",
abstract = "Introduction: Countless antidepressant randomized trials were conducted and showed statistically significant benefits of selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) over placebo. Meanwhile, critics are increasing regarding the efficacy of antidepressants in the treatment of MDD because at least a proportion of clinical trials could be hampered by various biases. In contrast, number of failed trials is increasing in the recent years which have made developing psychiatric medications progressively more time-consuming and expensive. Areas covered: Biases and related issues in clinical trials for antidepressants can be identified as an important common contributing factor to the two paradoxical phenomenon. This review identifies possible biases that can occur before, during, and after clinical trials of antidepressant. Expert commentary: Recent studies not only may over-estimate efficacy of antidepressants, but also may exaggerate placebo response because of various biases. Sponsorship and publication biases have been one of the targets of the criticism and ethical debate. Thus, initiating new trend of research by re-organizing academic-industry partnership will be the most important task in the next five years.",
keywords = "Antidepressant, bias, clinical trial, placebo response, review",
author = "Wang, {Sheng Min} and Changsu Han and Lee, {Soo Jung} and Jun, {Tae Youn} and Patkar, {Ashwin A.} and Masand, {Prakash S.} and Pae, {Chi Un}",
year = "2018",
month = "1",
day = "2",
doi = "10.1080/17512433.2017.1377070",
language = "English",
volume = "11",
pages = "15--25",
journal = "Expert Review of Clinical Pharmacology",
issn = "1751-2433",
publisher = "Expert Reviews Ltd.",
number = "1",

}

TY - JOUR

T1 - Efficacy of antidepressants

T2 - bias in randomized clinical trials and related issues

AU - Wang, Sheng Min

AU - Han, Changsu

AU - Lee, Soo Jung

AU - Jun, Tae Youn

AU - Patkar, Ashwin A.

AU - Masand, Prakash S.

AU - Pae, Chi Un

PY - 2018/1/2

Y1 - 2018/1/2

N2 - Introduction: Countless antidepressant randomized trials were conducted and showed statistically significant benefits of selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) over placebo. Meanwhile, critics are increasing regarding the efficacy of antidepressants in the treatment of MDD because at least a proportion of clinical trials could be hampered by various biases. In contrast, number of failed trials is increasing in the recent years which have made developing psychiatric medications progressively more time-consuming and expensive. Areas covered: Biases and related issues in clinical trials for antidepressants can be identified as an important common contributing factor to the two paradoxical phenomenon. This review identifies possible biases that can occur before, during, and after clinical trials of antidepressant. Expert commentary: Recent studies not only may over-estimate efficacy of antidepressants, but also may exaggerate placebo response because of various biases. Sponsorship and publication biases have been one of the targets of the criticism and ethical debate. Thus, initiating new trend of research by re-organizing academic-industry partnership will be the most important task in the next five years.

AB - Introduction: Countless antidepressant randomized trials were conducted and showed statistically significant benefits of selective serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine reuptake inhibitors (SNRIs) over placebo. Meanwhile, critics are increasing regarding the efficacy of antidepressants in the treatment of MDD because at least a proportion of clinical trials could be hampered by various biases. In contrast, number of failed trials is increasing in the recent years which have made developing psychiatric medications progressively more time-consuming and expensive. Areas covered: Biases and related issues in clinical trials for antidepressants can be identified as an important common contributing factor to the two paradoxical phenomenon. This review identifies possible biases that can occur before, during, and after clinical trials of antidepressant. Expert commentary: Recent studies not only may over-estimate efficacy of antidepressants, but also may exaggerate placebo response because of various biases. Sponsorship and publication biases have been one of the targets of the criticism and ethical debate. Thus, initiating new trend of research by re-organizing academic-industry partnership will be the most important task in the next five years.

KW - Antidepressant

KW - bias

KW - clinical trial

KW - placebo response

KW - review

UR - http://www.scopus.com/inward/record.url?scp=85038565541&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85038565541&partnerID=8YFLogxK

U2 - 10.1080/17512433.2017.1377070

DO - 10.1080/17512433.2017.1377070

M3 - Review article

C2 - 28893095

AN - SCOPUS:85038565541

VL - 11

SP - 15

EP - 25

JO - Expert Review of Clinical Pharmacology

JF - Expert Review of Clinical Pharmacology

SN - 1751-2433

IS - 1

ER -