Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— ALBERIO  

Official title:

A Multi-National, Multi-Center, DB, Placebo-Controlled, Parallel Group, Fixed Dose Efficacy & Safety Study of SR58611A 350 mg Twice Daily vs. Placebo in Adults With Major Depressive Disorder on Concomitant Treatment With Escitalopram 10mg/d

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432614
• Other study ID #: EFC6224
• Secondary ID: EudraCT 2006-004
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2007
• Last updated: March 24, 2009
• Start date: January 2007
• Est. completion date: February 2008

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.

The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score => 30

Exclusion Criteria:

• Patient is at immediate risk for suicidal behavior

• Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset

• Patients with a current depressive episode secondary to a general medical disorder

• Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder

• Patients with severe or unstable concomitant medical conditions

• Pregnant, breastfeeding, or likely to become pregnant during the study

• Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram

The investigator will evaluate whether there are other reasons why a patient may not participate.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Drug:
• SR58611A
oral administration
• escitalopram
oral administration
• placebo
oral administration

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Diegem
Estonia	Sanofi-Aventis Administrative Office	Tatari
Finland	Sanofi-Aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Greece	Sanofi-Aventis Administrative Office	Athens
India	Sanofi-Aventis Administrative Office	Mumbai
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul
Malaysia	Sanofi-Aventis Administrative Office	Kuala Lumpur
Morocco	Sanofi-Aventis Administrative Office	Casablanca
Taiwan	Sanofi-Aventis Administrative Office	Taipei
Tunisia	Sanofi-Aventis Administrative Office	Megrine
Turkey	Sanofi-Aventis Administrative Office	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  Estonia,  Finland,  France,  Germany,  Greece,  India,  Korea, Republic of,  Malaysia,  Morocco,  Taiwan,  Tunisia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Hamilton Depression Rating scale (HAM-D) total score		8 weeks	No
Secondary	Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score		8 weeks	No