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
EudraCT/CTIS number	2005-004881-17
Secondary identifying numbers	CL3-20098-047

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

Study design	Randomised double-blind placebo-controlled parallel-group study.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Agomelatine
Primary outcome measure	Montgomery-Asberg Depression Rating Scale (MADRS) questionnaire
Secondary outcome measures	Safety of agomelatine in addition to a mood stabiliser
Overall study start date	18/07/2006
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website	http://www.servier.com/
"ROR"	https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Summary results are published in https://clinicaltrials.servier.com. For interventional Phase III studies ending after the 1st January 2014, the results are/will be published in scientific literature.
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?
Basic results				No	No
Results article	results	01/01/2016		Yes	No

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.