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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

A meta-analysis of the primary efficacy measure of aripiprazole versus placebo in randomized, placebo-controlled trials. SMD: standardized mean difference, CIs: confidence intervals.
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Figure 3: A meta-analysis of the primary efficacy measure of aripiprazole versus placebo in randomized, placebo-controlled trials. SMD: standardized mean difference, CIs: confidence intervals.

Mentions: The pooled SMDs for the primary efficacy measure was statistically significant, pointing out the significant reduction of depressive symptoms after aripiprazole augmentation vs. placebo to current antidepressant treatment (pooled SMD=-2.182, z=-3.135, p=0.002) (Figure 3). The heterogeneity was also significant, pointing out the substantial variability of in the magnitude of treatment difference and underlying variance influencing on the outcome among study (I2=98.8%, Q-value=341.7, p<0.001). The pooled SMD was repeatedly calculated and analyzed with omission of one study at a time to perform a sensitivity analysis; the pooled SMD of the primary efficacy measure ranged from -2.673 to -1.655 (all 95% CIs indicated the statistical significance: range from -4.025 to -0.255), proposing that no one study has strongly impacted the pooled SMD. The Egger test was not statistically significant (t=0.416, p=0.705), indicating no publication bias.


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)

A meta-analysis of the primary efficacy measure of aripiprazole versus placebo in randomized, placebo-controlled trials. SMD: standardized mean difference, CIs: confidence intervals.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 3: A meta-analysis of the primary efficacy measure of aripiprazole versus placebo in randomized, placebo-controlled trials. SMD: standardized mean difference, CIs: confidence intervals.
Mentions: The pooled SMDs for the primary efficacy measure was statistically significant, pointing out the significant reduction of depressive symptoms after aripiprazole augmentation vs. placebo to current antidepressant treatment (pooled SMD=-2.182, z=-3.135, p=0.002) (Figure 3). The heterogeneity was also significant, pointing out the substantial variability of in the magnitude of treatment difference and underlying variance influencing on the outcome among study (I2=98.8%, Q-value=341.7, p<0.001). The pooled SMD was repeatedly calculated and analyzed with omission of one study at a time to perform a sensitivity analysis; the pooled SMD of the primary efficacy measure ranged from -2.673 to -1.655 (all 95% CIs indicated the statistical significance: range from -4.025 to -0.255), proposing that no one study has strongly impacted the pooled SMD. The Egger test was not statistically significant (t=0.416, p=0.705), indicating no publication bias.

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