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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.

Pae CU, Seo HJ, Lee BC, Seok JH, Jeon HJ, Paik JW, Kwak KP, Ham BJ, Han C, Lee SJ - Psychiatry Investig (2014)

Bottom Line: Extracted data were delivered into and run by the Comprehensive Meta Analysis program v2.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.

View Article: PubMed Central - PubMed

Affiliation: 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.

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.

No MeSH data available.


Related in: MedlinePlus

The disposition of selected studies for the meta-analysis. RCT: randomized placebo-controlled trial, OLS: open-label study.
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Figure 1: The disposition of selected studies for the meta-analysis. RCT: randomized placebo-controlled trial, OLS: open-label study.

Mentions: We included studies of AA in the treatment of MDD. The studies to be included in the present meta-analysis should fulfill following criteria: 1) prospective design with commonly adopted in clinical trials as efficacy measures such as Hamilton Depression Rating scale (HAMD), e.t.c.; 2) at least one or more follow-up visit; 3) study duration at least for 4 weeks; 4) OLS or RCT for aripiprazole; and 5) published in English-based peer-reviewed journal. There were no requirements or restrictions in search of data for date. However, post-hoc analysis of RCT, redundant studies, case-report or letter-to-the-editor concerning interesting or rare case illustration in the use of aripiprazole for treating MDD were not included. If necessary, the study authors were contacted for additional information. Figure 1 summarizes the disposition of the included studies for the present meta-analysis.


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 CU, Seo HJ, Lee BC, Seok JH, Jeon HJ, Paik JW, Kwak KP, Ham BJ, Han C, Lee SJ - Psychiatry Investig (2014)

The disposition of selected studies for the meta-analysis. RCT: randomized placebo-controlled trial, OLS: open-label study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4225200&req=5

Figure 1: The disposition of selected studies for the meta-analysis. RCT: randomized placebo-controlled trial, OLS: open-label study.
Mentions: We included studies of AA in the treatment of MDD. The studies to be included in the present meta-analysis should fulfill following criteria: 1) prospective design with commonly adopted in clinical trials as efficacy measures such as Hamilton Depression Rating scale (HAMD), e.t.c.; 2) at least one or more follow-up visit; 3) study duration at least for 4 weeks; 4) OLS or RCT for aripiprazole; and 5) published in English-based peer-reviewed journal. There were no requirements or restrictions in search of data for date. However, post-hoc analysis of RCT, redundant studies, case-report or letter-to-the-editor concerning interesting or rare case illustration in the use of aripiprazole for treating MDD were not included. If necessary, the study authors were contacted for additional information. Figure 1 summarizes the disposition of the included studies for the present meta-analysis.

Bottom Line: Extracted data were delivered into and run by the Comprehensive Meta Analysis program v2.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.

View Article: PubMed Central - PubMed

Affiliation: 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.

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.

No MeSH data available.


Related in: MedlinePlus