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
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Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3 (PDF/541.2 KB) (updated)
Draft: consultation open
First published: 07/09/2023
Last updated: 15/09/2023
Consultation dates: 15/09/2023 to 31/03/2024
EMA/CHMP/185423/2010 Rev.3 -
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Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3 (PDF/93.21 KB)
Draft: consultation closed
First published: 18/11/2016
Last updated: 18/11/2016
Consultation dates: 18/11/2016 to 28/02/2017
EMA/CHMP/183826/2016
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Guideline on clinical investigation of medicinal products in the treatment of depression - Revision 2 (PDF/239.42 KB)
Adopted
First published: 30/05/2013
Last updated: 30/05/2013
Legal effective date: 01/12/2013
EMA/CHMP/185423/2010 Rev. 2 -
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Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 2 (PDF/198.29 KB)
Draft: consultation closed
First published: 11/10/2011
Last updated: 11/10/2011
Consultation dates: 22/09/2011 to 31/03/2012
EMA/CHMP/185423/2010, Rev 2 -
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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 (PDF/43.35 KB)
Draft: consultation closed
First published: 09/10/2000
Last updated: 09/10/2000
Consultation dates: 24/09/2009 to 31/12/2009
EMEA/CHMP/EWP/484366/2009
- Clinical efficacy and safety: nervous system
- Directive 2001/83/EC
Exposure to medicinal products during pregnancy: need for post-authorisation data- Adjustment for baseline covariates in clinical trials
- Clinical investigation of medicinal products for the treatment and prevention of bipolar disorder
- Extrapolation of results from clinical studies conducted outside the EU to the EU population
- ICH E1 Population exposure: the extent of population exposure to assess clinical safety
- ICH E4 Dose response information to support drug registration
- ICH E6 (R1) Good clinical practice
- ICH E7 Studies in support of special populations: geriatrics
- Questions and answers on the ICH E7 guideline on the studies in support of special populations: geriatrics
- ICH E8 General considerations for clinical trials
- ICH E9 Statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- ICH E11 Clinical investigation of medicinal products in the paediatric population
- Investigation of drug interactions
- Non-clinical investigation of the dependence potential of medicinal products
- Missing data in confirmatory clinical trials
- Pharmacokinetic studies in man