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

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: placebo; Drug: SR58611A; Drug: escitalopram

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; SR58611A 350mg twice daily with escitalopram 10mg once daily	Drug: SR58611A; oral administration; Drug: escitalopram; oral administration
Active Comparator: Group 2; placebo with escitalopram 10mg once daily	Drug: escitalopram; oral administration
Placebo Comparator: Group 3; placebo	Drug: placebo; oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Hamilton Depression Rating scale (HAM-D) total score	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score	8 weeks

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: February 7, 2007
• First Submitted That Met QC Criteria: February 7, 2007
• First Posted (Estimate): February 8, 2007

Study Record Updates

• Last Update Posted (Estimate): March 25, 2009
• Last Update Submitted That Met QC Criteria: March 24, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Mood Disorder; Depressive Disorder; Mental Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agonists; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Adrenergic beta-Agonists; Citalopram; Amibegron
• Other Study ID Numbers: EFC6224; EudraCT 2006-004146-16