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

This document provides guidance on the evaluation of new medicinal products intended for the use in the treatment of bipolar disorder.

Keywords: Bipolar disorder, clinical investigation

Current effective version

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

AdoptedLegal effective date: 01/10/2001Reference Number: CPMP/EWP/567/98

Document history

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

Consultation dates: 28/07/2016 to 31/10/2016Draft: consultation closedReference 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).