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

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

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

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

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...

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

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

Consultation dates: 22/02/2011 to 31/08/2011Draft: consultation closedReference 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)

Consultation dates: 22/04/2010 to 31/07/2010Draft: consultation closedReference 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

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

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...

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