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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00432614
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : March 25, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SR58611A Drug: escitalopram Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

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
Drug: placebo
oral administration

Primary Outcome Measures :
  1. Change from baseline in Hamilton Depression Rating scale (HAM-D) total score [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00432614

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Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Tatari, Estonia
Sanofi-Aventis Administrative Office
Helsinki, Finland
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Berlin, Germany
Sanofi-Aventis Administrative Office
Athens, Greece
Sanofi-Aventis Administrative Office
Mumbai, India
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Sanofi-Aventis Administrative Office
Megrine, Tunisia
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00432614    
Other Study ID Numbers: EFC6224
EudraCT 2006-004146-16
First Posted: February 8, 2007    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009
Keywords provided by Sanofi:
Mental Disorder
Mood Disorder
Depressive Disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents