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Tobias Gerhard Receives NIMH Grant

Tobias Gerhard is principal investigator of “Safety of Second Generation Antipsychotics for Adult Depression” to assess the safety of second-generation antipsychotic (SGA) medication augmentation in the treatment of adult depression.Inadequate response to initial antidepressant treatment is common and more than half of depressed patients require multiple sequential treatment steps to achieve remission of depressive symptoms. Despite modest efficacy, augmentation of antidepressants with SGAs is the most strongly supported and fastest growing pharmacological treatment alternative for treatment-resistant depression. Yet the discovery of several serious SGA-associated adverse effects in other clinical populations, most strikingly a >50% increase in mortality risk in elderly patients with dementia, raises critical questions about the safety of SGAs in depression as it is not known whether and to what extent these risks generalize to non-elderly adults who receive SGA augmentation for depression. The combined experience of randomized clinical trials of SGAs for depression falls far short of sufficient power to detect a mortality risk in depression comparable to that observed in dementia.

Ten years of near national Medicaid data (2001-2010) with approximately 80,000 non-elderly adults with depression and incomplete response to antidepressant monotherapy will examine the real-world safety of SGA augmentation. The results will help inform clinical, regulatory and health care policy efforts to improve the management of treatment-resistant depression and support or refute the need for large-scale prospective safety studies.

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