Clinical development of medicinal products for the treatment and prevention of bipolar disorder - Scientific guideline

With the transition of Diagnostic and Statistical Manual of Mental Disorders (DSM) IV into DSM-5, bipolar and related disorders have been separated from depressive disorders, and BD II is no longer considered a milder form of BD I. Other changes in the DSM, such as addition of new specifiers, have subsequent implications for identifying patients both in clinical and research settings. 

Keywords: Bipolar disorder, mania, bipolar depression, acute treatment, maintenance treatment, recurrence prevention

Current effective version (under review, see below)

Note for guidance on clinical investigation of medicinal products for the treatment and prevention of bipolar disorder

AdoptedReference Number: CPMP/EWP/567/98Legal effective date: 01/10/2001

Document history - Revision 1

Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder - Revision 1

Draft: consultation closedConsultation dates: 09/09/2024 to 31/03/2025Reference Number: EMA/CHMP/406037/2024 Rev. 1Summary:

This guideline replaces Guideline on clinical investigation of medicinal products in the treatment and prevention of bipolar disorder (CPMP/EWP/567/98). 

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Concept paper on the need for revision of the note for guidance on clinical investigation of medicinal products for the treatment and prevention of bipolar disorder

Draft: consultation closedConsultation dates: 28/07/2016 to 31/10/2016Reference Number: EMA/CHMP/318360/2015Summary:

Bipolar Disorder (BD) I and II have long been well known psychiatric diseases that can be controlled with psychopharmacological and behavioural treatment. Over the past decades its prevalence remained stable (BD I 0.6% and BD II 0.4%, worldwide). Aetiology and pathophysiology of BD remain still largely unknown, however, recent research effort, especially genetic research using Genome Wide Association Studies (GWAS) and Copy Number Variations (CNVs) methodologies in extremely large samples, has shed some light into the neurobiology (1). Bipolar Disorder is now considered a bridging disease belonging to both the psychotic and the mood spectrum, with different dimension differentially involved in individual patients (2).