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
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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