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

Not Applicable

Completed

• Conditions: Major depressive episode; Depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN28588282
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-24
• Study Completion: 2008-12-31
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS) questionnaire

Secondary Outcome Measures

Name	Time	Method
Safety of agomelatine in addition to a mood stabiliser