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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

SR58611A

escitalopram

placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Mental Disorder, Mood Disorder, Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

SR58611A 350mg twice daily with escitalopram 10mg once daily

placebo with escitalopram 10mg once daily

placebo

Outcomes

Primary Outcome Measures

Change from baseline in Hamilton Depression Rating scale (HAM-D) total score

Secondary Outcome Measures

Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score

Full Information

NCT ID

NCT00432614

First Posted

February 7, 2007

Last Updated

March 24, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00432614

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Mental Disorder, Mood Disorder, Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

510 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

SR58611A 350mg twice daily with escitalopram 10mg once daily

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

placebo with escitalopram 10mg once daily

Arm Title

Group 3

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

SR58611A

Intervention Description

oral administration

Intervention Type

Drug

Intervention Name(s)

escitalopram

Intervention Description

oral administration

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral administration

Primary Outcome Measure Information:

Title

Change from baseline in Hamilton Depression Rating scale (HAM-D) total score

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name