Clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia - Scientific guideline

This document provides guidance on the development of medicinal products, including depot preparations, for the treatment of schizophrenia. It addresses the main requirements with regard to study design, patient population and outcome measures.

Keywords: Schizophrenia, cognitive deficit, negative symptoms, schizophrenia, partial response, treatment resistant schizophrenia, short term treatment, maintenance treatment

Current effective version

Guideline on clinical investigation of medicinal products, including depot preparations, in the treatment of schizophrenia - Revision 1

Adopted Reference Number: EMA/CHMP/40072/2010 Rev. 1 Legal effective date: 01/04/2013 Summary:

This guideline replaces NfG on clinical investigation of medicinal products in the treatment of schizophrenia (CPMP/EWP/559/95).

Document history - Revision 1 (current)

Guideline on clinical investigation of medicinal products, including depot preparations, in the treatment of schizophrenia - Revision 1

Adopted Reference Number: EMA/CHMP/40072/2010 Rev. 1 Legal effective date: 01/04/2013 Summary:

This guideline replaces NfG on clinical investigation of medicinal products in the treatment of schizophrenia (CPMP/EWP/559/95).

Overview of comments received on 'guideline on clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia' - Revision 1

Reference Number: EMA/CHMP/57220/2012

Concept paper on the need for revision of the appendix to the note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia – methodology of clinical trials concerning the develo...

Adopted Reference Number: EMA/CHMP/457223/2011 Legal effective date: 22/09/2011

Draft guideline on clinical investigation of medicinal products in the treatment of schizophrenia

Draft: consultation closed Consultation dates: 22/02/2011 to 31/08/2011 Reference Number: CHMP/40072/2010

Concept paper on the need for revision of the note for guidance on clinical investigation of medicinal products in the treatment of schizophrenia (CPMP/EWP/559/95)

Draft: consultation closed Consultation dates: 22/04/2010 to 31/07/2010 Reference Number: EMA/CHMP/EWP/179360/2010

Document history - First version

Note for guidance on the clinical investigatiom of medicinal products in the treatment of schizophrenia

Adopted Reference Number: CPMP/EWP/595/95 Legal effective date: 01/08/1998

Appendix to the note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia - Methodology of clinical trials concerning the development of depot preparations of approved medici...

Adopted Reference Number: CPMP/EWP/49/01 Legal effective date: 01/08/2003