A Meta-Analysis Comparing Open-Label versus Placebo-Controlled Clinical Trials for Aripiprazole Augmentation in the Treatment of Major Depressive Disorder: Lessons and Promises.
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.


CONCLUSIONS
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.
Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea. ; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Duram, NC, USA.
Chi-Un
CU
Pae
Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.
Ho-Jun
HJ
Seo
Department of Neuropsychiatry, College of Medicine, Hallym University, Seoul, Republic of Korea.
Boung Chul
BC
Lee
Department of Psychiatry, Yonsei University College of Medicine, Seoul, Republic of Korea.
Jeong-Ho
JH
Seok
Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Hong Jin
HJ
Jeon
Department of Psychiatry, Kyunghee University College of Medicine, Seoul, Republic of Korea.
Jong-Woo
JW
Paik
Department of Neuropsychiatry, School of Medicine, Dongguk University, Gyeongju, Republic of Korea.
Kyung-Phil
KP
Kwak
Department of Psychiatry, College of Medicine, Korea University, Seoul, Republic of Korea.
Byung-Joo
BJ
Ham
Department of Psychiatry, College of Medicine, Korea University, Seoul, Republic of Korea.
Changsu
C
Han
Department of Psychiatry, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea.
Soo-Jung
SJ
Lee
Aripiprazole; Augmentation; Depression; Open-label study; Randomized-controlled clinical trials