A meta-analysis of factors impacting detection of antidepressant efficacy in clinical trials: the importance of academic sites
| Autor: | Philip T. Ninan, Christine J. Guico-Pabia, Boadie W. Dunlop, Rana Fayyad, Chuan-Chuan Wun, Jeff Musgnung, Michael E. Thase |
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| Rok vydání: | 2012 |
| Předmět: |
Pharmacology
medicine.medical_specialty Academic Medical Centers Clinical Trials as Topic Depressive Disorder Major business.industry Hamilton Rating Scale for Depression Venlafaxine medicine.disease Placebo Antidepressive Agents Clinical trial Desvenlafaxine Psychiatry and Mental health Treatment Outcome Strictly standardized mean difference Internal medicine Meta-analysis medicine Major depressive disorder Humans Original Article business Clinical psychology medicine.drug |
| Zdroj: | Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology. 37(13) |
| ISSN: | 1740-634X |
| Popis: | Variability in placebo response greatly complicates the design, conduct, and interpretation of clinical trials of antidepressant medications. To identify factors that impact detection of antidepressant–placebo differences, we conducted a meta-analysis of all relevant phase II–IV clinical trials for major depressive disorder conducted by the manufacturer of venlafaxine and desvenlafaxine completed by March 2011. We examined 15 factors potentially relevant to trial outcomes, using the standardized mean difference on the Hamilton Rating Scale for Depression (HAM-D17) score as the primary outcome. Thirty trials comprising 8933 patients were included. In univariate analyses, antidepressant efficacy (ie, drug vs placebo difference) was predicted most strongly (β=3.74, p=0.0002) by the proportion of patients in the trial enrolled from academic sites. Other factors predicting larger drug–placebo differences included lower participant completion rate, fewer post-baseline study visits, earlier year of study, and study drug (venlafaxine>desvenlafaxine). In multivariate meta-regression modeling, only the proportion of patients from academic sites maintained statistical significance as a predictor of drug–placebo separation for both HAM-D17 continuous score change (β=2.24, p=0.034) and response rate (β=2.26, p=0.035). Including a higher proportion of academic sites may increase the ability to detect differences between active drug and placebo in clinical trials of major depressive disorder. |
| Databáze: | OpenAIRE |
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