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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

Authors
Pae, Chi-UnSeo, Ho-JunLee, Boung ChulSeok, Jeong-HoJeon, Hong JinPaik, Jong-WooKwak, Kyung-PhilHam, Byung-JooHan, ChangsuLee, Soo-Jung
Issue Date
10월-2014
Publisher
KOREAN NEUROPSYCHIATRIC ASSOC
Keywords
Open-label study; Randomized-controlled clinical trials; Aripiprazole; Augmentation; Depression
Citation
PSYCHIATRY INVESTIGATION, v.11, no.4, pp.371 - 379
Indexed
SCIE
SSCI
SCOPUS
KCI
Journal Title
PSYCHIATRY INVESTIGATION
Volume
11
Number
4
Start Page
371
End Page
379
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/97202
DOI
10.4306/pi.2014.11.4.371
ISSN
1738-3684
Abstract
Objective The present study is to provide whether open-label studies (OLS) may properly foresee the efficacy of randomized, placebocontrolled 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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