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EMEA: Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products in the treatment of depression with regard to treatment resistant depression

23.10.2009
There are new proposals with operationalized criteria for TRD available allowing definition of a patient population, which suffers from clinically relevant impairment and requires alternative treatment options including augmentation with add-on strategies or monotherapy options. Therefore CHMP recommends to update the guideline on the treatment of depression with regard to these issues of TRD.