Clinical investigation of medicinal products in the treatment of depression - Scientific guideline

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

Guideline on clinical investigation of medicinal products in the treatment of depression - Revision 2

Adopted Reference Number: EMA/CHMP/185423/2010 Rev. 2 Legal effective date: 01/12/2013

Document history - Revision 3

Overview of comments received on draft guideline on clinical investigation of medicinal products in the treatment of depression (EMA/CHMP/185423/2010, Rev.3)

Reference Number: EMA/117920/2025

Guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3

Adopted Reference Number: EMA/CHMP/185423/2010 Rev.3 Legal effective date: 30/09/2025

Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3

Draft: consultation closed Consultation dates: 15/09/2023 to 31/03/2024 Reference Number: EMA/CHMP/185423/2010 Rev.3 Summary:

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.

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3

Draft: consultation closed Consultation dates: 18/11/2016 to 28/02/2017 Reference Number: EMA/CHMP/183826/2016 Summary:

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.

Document history - Revision 2

Guideline on clinical investigation of medicinal products in the treatment of depression - Revision 2

Adopted Reference Number: EMA/CHMP/185423/2010 Rev. 2 Legal effective date: 01/12/2013

Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 2

Draft: consultation closed Consultation dates: 22/09/2011 to 31/03/2012 Reference Number: EMA/CHMP/185423/2010, Rev 2 Summary:

This guideline replaces guideline NfG on clinical investigation of medicinal products in the treatment of depression (CPMP/EWP/518/97, Rev 1).

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

Draft: consultation closed Consultation dates: 24/09/2009 to 31/12/2009 Reference Number: EMEA/CHMP/EWP/484366/2009

Document history - Revision 1

Note for guidance on clinical investigation of medicinal products for treatment of depression - Revision 1

Adopted Reference Number: CPMP/EWP/518/97, Rev. 1 Legal effective date: 01/10/2002