FindTrial
Sign In

Efficacy and safety of agomelatine (25 mg/day with potential adjustment at 50 mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode. An 8-week randomised, double-blind, controlled, parallel groups study followed by a double-blind extension treatment period up to 1 year.

Efficacy and safety of agomelatine (25 mg/day with potential adjustment at 50 mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode. An 8-week randomised, double-blind, controlled, parallel groups study followed by a double-blind extension treatment period up to 1 year.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004881-17-AT
Enrollment
300
Registered
2006-03-28
Start date
2006-05-01
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive episode in the framework of bipolar disorder MedDRA version: 7.0 Level: PT Classification code 10004939

Interventions

Product Name: S20098 Product Code: S20098 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Agomelatine CAS Number: 138112-76-2 Current Sponsor code: S20098 Concentration unit: mg milligram

Sponsors

Institut de Recherches Internationales Servier
Lead Sponsor
Laboratorios Servier S.L. (For Spain only)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - In or out patients of both genders, - over 18 years old, - fulfilling DSM-IV-TR criteria for Bipolar I disorder with current Major Depressive Episode - Treated with a mood stabilizer (lithium or valproic acid). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Other psychiatric conditions according to DSM-IV TR, - Pregnancy (positive ßhCG blood test), - Use of psychotropic medications other than lithium, valproic acid and lorazepam.

Design outcomes

Primary

MeasureTime frame
Main Objective: Primary objective: to assess the antidepressant efficacy of agomelatine compared to placebo in addition to a mood stabilizer. ;Secondary Objective: Secondary objective: to assess the safety of agomelatine in addition to a mood stabilizer.;Primary end point(s): MADRS total score—

Countries

Austria, Finland, Germany, Netherlands, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026