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

Current effective version

PDF iconRevision 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

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconConcept paper (revision of the appendix)

PDF iconDraft guideline

PDF iconConcept 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

PDF iconAdopted guideline

PDF iconAppendix on depot preparations

In operation: 01/08/1998–31/03/2013

In operation: 01/08/2003–31/03/2013

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