This document provides guidance on the development of medicinal products for acute and long-term treatment of major depressive disorder.
Keywords: Major depression, major depressive episode, partial response, treatment resistance, suicidal thoughts, suicidal behaviour, suicide, acute treatment, maintenance treatment, recurrence prevention
Current effective version - currently under revision, see below
Guideline on clinical investigation of medicinal products in the treatment of depression - Revision 2
English (EN) (239.42 KB - PDF)
Document history - Revision 3
Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3
The present document should be considered as general guidance on the development of medicinal products for acute and long-term treatment of Major Depressive Disorder (MDD). It updates and replaces the previous guideline (EMA/CHMP/185423/2010 Rev. 2). The main focus is on major depressive episodes that occur in the context of MDD. Bipolar and related disorders are separated from the depressive disorders in DSM-5 and possible extrapolations in alignment with the bipolar guidance document will also be addressed.
English (EN) (541.2 KB - PDF)
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3
The current guideline needs revision covering the latest developments with regard to requirements for clinical trials in partial and non-responders with MDD and options of targeting new functional domains. In addition, it may include requirements to increase depression clinical trials efficiency.
English (EN) (93.21 KB - PDF)
Document history - Revision 2
Guideline on clinical investigation of medicinal products in the treatment of depression - Revision 2
English (EN) (239.42 KB - PDF)
Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 2
This guideline replaces guideline NfG on clinical investigation of medicinal products in the treatment of depression (CPMP/EWP/518/97, Rev 1).
English (EN) (198.29 KB - PDF)
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 - Revision 2
English (EN) (43.35 KB - PDF)
Document history - Revision 1
Note for guidance on clinical investigation of medicinal products for treatment of depression - Revision 1
English (EN) (159.78 KB - PDF)
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