Condition category
Mental and Behavioural Disorders
Date applied
31/07/2006
Date assigned
24/08/2006
Last edited
18/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michel Bourin

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2005-004881-17

ClinicalTrials.gov number

Protocol/serial number

CL3-20098-047

Study information

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

Acronym

Study hypothesis

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

Ramsay Health Ethics Committee, 23/03/2006

Study design

Randomised double-blind placebo-controlled parallel-group study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Major depressive episode

Intervention

Agomelatine versus placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Agomelatine

Primary outcome measures

Montgomery-Asberg Depression Rating Scale (MADRS) questionnaire

Secondary outcome measures

Safety of agomelatine in addition to a mood stabiliser

Overall trial start date

18/07/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Hepatic or renal failure
2. Abnormal thyroid function
3. Pregnancy
4. Other psychiatric conditions according to DSM-IV TR

Recruitment start date

18/07/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

France

Trial participating centre

Centre Hospitalier Universitaire de Nantes
Nantes
44093
France

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

http://clinicaltrials.servier.com/wp-content/uploads/CL3-20098-047_synopsis_report.pdf

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/25999335

Publication citations

Additional files

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.