Efficacy and safety of agomelatine given orally compared to placebo, in addition to a mood stabiliser in bipolar I patients with a current major depressive episode. An eight week randomised, double-blind, controlled, parallel group study followed by a double-blind extension treatment period up to one year

ISRCTN	ISRCTN28588282
DOI	https://doi.org/10.1186/ISRCTN28588282
Clinical Trials Information System (CTIS)	2005-004881-17
Protocol serial number	CL3-20098-047
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 31/07/2006
Registration date: 24/08/2006
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Prof Michel Bourin
Scientific

Centre Hospitalier Universitaire de Nantes
5 Allée de l'Ile Gloriette
Nantes
44093
France

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled parallel-group study.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Efficacy and safety of agomelatine given orally compared to placebo, in addition to a mood stabiliser in bipolar I patients with a current major depressive episode. An eight week randomised, double-blind, controlled, parallel group study followed by a double-blind extension treatment period up to one year
Study objectives	To assess the efficacy of agomelatine compared to placebo in addition to a mood stabiliser in bipolar I patients with a current major depressive episode.
Ethics approval(s)	Ramsay Health Ethics Committee, 23/03/2006
Health condition(s) or problem(s) studied	Major depressive episode
Intervention	Agomelatine versus placebo
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Agomelatine
Primary outcome measure(s)	Montgomery-Asberg Depression Rating Scale (MADRS) questionnaire
Key secondary outcome measure(s)	Safety of agomelatine in addition to a mood stabiliser
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Patients of both genders, over 18 years old 2. Fulfilling The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for bipolar I disorder with current major depressive episode 3. Treated with a mood stabiliser
Key exclusion criteria	1. Hepatic or renal failure 2. Abnormal thyroid function 3. Pregnancy 4. Other psychiatric conditions according to DSM-IV TR
Date of first enrolment	18/07/2006
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

France

Study participating centre

Centre Hospitalier Universitaire de Nantes

Nantes
44093
France

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2016		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement were updated.
25/01/2018: Publication plan and IPD sharing statement (+flag) added. Kept estimated pub date empty.
25/01/2018: Publication plan and IPD sharing statement added.
18/12/2017: results summary added.
01/11/2016: Publication reference added.