The US Food and Drug Administration (FDA) has requested data from antidepressant manufacturers for an analysis of adult suicidality data from short-term placebo-controlled trials. GSK elected to conduct an analysis of its own data from short- and long-term placebo-controlled paroxetine trials in adults, building upon what was done in previous analyses and the developing expertise in the field. Please find below the descriptions of and links to documents related to the 2006 analysis.
A summary of the results from the 2006 analysis has been submitted to regulatory agencies in the United States, Europe, and other countries around the world. This summary (also known as a Briefing Document) provides both safety data (related to suicidal behavior and ideation) and efficacy data (how well symptoms of psychiatric disorders respond to paroxetine), as well as GSK's conclusions from the analysis.
These Appendices provide the datasets and clinical narratives that are referenced in the Briefing Document. Note that Appendix I contains the data analysis plan.
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