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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 
 PSYCHIATRY INVESTIGATION, Vol.11(4) : 371-379, 2014 
Journal Title
Issue Date
Aripiprazole ; Augmentation ; Depression ; Open-label study ; Randomized-controlled clinical trials
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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1. College of Medicine (의과대학) > Dept. of Psychiatry (정신과학교실) > 1. Journal Papers
Yonsei Authors
Seok, Jeong Ho(석정호) ORCID logo https://orcid.org/0000-0002-9402-7591
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