A meta-analysis comparing open-label versus placebo-controlled clinical trials for aripiprazole augmentation in the treatment of major depressive disorder: Lessons and promises

Chi Un Pae, Ho Jun Seo, Boung Chul Lee, Jeong Ho Seok, Hong Jin Jeon, Jong Woo Paik, Kyung Phil Kwak, Byung-Joo Ham, Changsu Han, Soo Jung Lee

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective The present study is to provide whether open-label studies (OLS) may properly foresee the efficacy of randomized, placebo-controlled trials (RCTs) using OLSs and RCTs data for aripiprazole in the treatment of MDD, with the use of meta-analysis approach. Methods A search of the studies used the key terms “depression and aripiprazole” from the databases of PubMed/PsychInfo from Jan 2005 through July 2013. The data were selected and verified for publication in English-based peer-reviewed journals based on rigorous inclusion criteria. Extracted data were delivered into and run by the Comprehensive Meta Analysis program v2. Results The pooled SMDs for the primary efficacy measure was statistically significant, pointing out the significant reduction of depressive symptoms after aripiprazole augmentation (AA) to current antidepressant treatment in OLSs (pooled SMD=-2.114, z=-9.625, p<0.001); similar results were also found in RCTs (pooled SMD=-2.202, z=-6.862, p<0.001). The meta-regression analysis revealed no influence of the study design for treatment outcome. Conclusion There was no difference in the treatment effects of aripiprazole as an augmentation therapy in both OLSs and RCTs, indicating that open-label design may be a potentially useful predictor for treatment outcomes of controlled-clinical trials. The proper conduction of OLSs may provide informative, useful and preliminary clinical data and factors to be involved in controlled-clinical trials, by which we may have better understanding on the role of AA (e.g., dosing issues, proper duration of treatment, specific population for AA) implicated in the treatment of MDD in clinical practice.

Original languageEnglish
Pages (from-to)371-379
Number of pages9
JournalPsychiatry Investigation
Volume11
Issue number4
DOIs
Publication statusPublished - 2014

Fingerprint

Controlled Clinical Trials
Major Depressive Disorder
Meta-Analysis
Placebos
Randomized Controlled Trials
Therapeutics
Depression
PubMed
Antidepressive Agents
Publications
Aripiprazole
Regression Analysis
Databases
Population

Keywords

  • Aripiprazole
  • Augmentation
  • Depression
  • Open-label study
  • Randomized-controlled clinical trials

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Biological Psychiatry

Cite this

A meta-analysis comparing open-label versus placebo-controlled clinical trials for aripiprazole augmentation in the treatment of major depressive disorder : Lessons and promises. / Pae, Chi Un; Seo, Ho Jun; Lee, Boung Chul; Seok, Jeong Ho; Jeon, Hong Jin; Paik, Jong Woo; Kwak, Kyung Phil; Ham, Byung-Joo; Han, Changsu; Lee, Soo Jung.

In: Psychiatry Investigation, Vol. 11, No. 4, 2014, p. 371-379.

Research output: Contribution to journalArticle

Pae, Chi Un ; Seo, Ho Jun ; Lee, Boung Chul ; Seok, Jeong Ho ; Jeon, Hong Jin ; Paik, Jong Woo ; Kwak, Kyung Phil ; Ham, Byung-Joo ; Han, Changsu ; Lee, Soo Jung. / A meta-analysis comparing open-label versus placebo-controlled clinical trials for aripiprazole augmentation in the treatment of major depressive disorder : Lessons and promises. In: Psychiatry Investigation. 2014 ; Vol. 11, No. 4. pp. 371-379.
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abstract = "Objective The present study is to provide whether open-label studies (OLS) may properly foresee the efficacy of randomized, placebo-controlled trials (RCTs) using OLSs and RCTs data for aripiprazole in the treatment of MDD, with the use of meta-analysis approach. Methods A search of the studies used the key terms “depression and aripiprazole” from the databases of PubMed/PsychInfo from Jan 2005 through July 2013. The data were selected and verified for publication in English-based peer-reviewed journals based on rigorous inclusion criteria. Extracted data were delivered into and run by the Comprehensive Meta Analysis program v2. Results The pooled SMDs for the primary efficacy measure was statistically significant, pointing out the significant reduction of depressive symptoms after aripiprazole augmentation (AA) to current antidepressant treatment in OLSs (pooled SMD=-2.114, z=-9.625, p<0.001); similar results were also found in RCTs (pooled SMD=-2.202, z=-6.862, p<0.001). The meta-regression analysis revealed no influence of the study design for treatment outcome. Conclusion There was no difference in the treatment effects of aripiprazole as an augmentation therapy in both OLSs and RCTs, indicating that open-label design may be a potentially useful predictor for treatment outcomes of controlled-clinical trials. The proper conduction of OLSs may provide informative, useful and preliminary clinical data and factors to be involved in controlled-clinical trials, by which we may have better understanding on the role of AA (e.g., dosing issues, proper duration of treatment, specific population for AA) implicated in the treatment of MDD in clinical practice.",
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AU - Lee, Boung Chul

AU - Seok, Jeong Ho

AU - Jeon, Hong Jin

AU - Paik, Jong Woo

AU - Kwak, Kyung Phil

AU - Ham, Byung-Joo

AU - Han, Changsu

AU - Lee, Soo Jung

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