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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	21 May 2018
Main ID:	ISRCTN28588282
Date of registration:	24/08/2006
Prospective Registration:	No
Primary sponsor:	Institut de Recherches Internationales Servier (France)
Public 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
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
Date of first enrolment:	18/07/2006
Target sample size:	300
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN28588282
Study type:	Interventional
Study design:	Randomised double-blind placebo-controlled parallel-group study. (Treatment)
Phase:	Not Applicable

Countries of recruitment
France

Contacts

Name:	Michel Bourin
Address:	Centre Hospitalier Universitaire de Nantes 5 Allée de l'Ile Gloriette 44093 Nantes France
Telephone:
Email:
Affiliation:

Name:
Address:
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Affiliation:

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Major depressive episode
Mental and Behavioural Disorders
Depression

Intervention(s)

Agomelatine versus placebo

Primary Outcome(s)

Montgomery-Asberg Depression Rating Scale (MADRS) questionnaire

Secondary Outcome(s)

Safety of agomelatine in addition to a mood stabiliser

Secondary ID(s)

2005-004881-17

CL3-20098-047

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ramsay Health Ethics Committee, 23/03/2006

Results

Results available:	Yes
Date Posted:
Date Completed:	31/12/2008
URL:

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