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

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/40072/2010 Rev. 1
Published09/10/2012
Effective from01/04/2013
KeywordsSchizophrenia, cognitive deficit, negative symptoms, schizophrenia, partial response, treatment resistant schizophrenia, short term treatment, maintenance treatment
DescriptionThis 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.


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Concept paper (revision of the appendix)


Draft guideline


Concept paper

In operation: 01/04/2013–present


Published: 23/01/2013


Published: 17/10/2011


Published: 22/02/2011


Published: 30/04/2010

First version

Adopted guideline


Appendix on depot preparations

In operation: 01/08/1998–31/03/2013


In operation: 01/08/2003–31/03/2013


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