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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00432614
First received: February 7, 2007
Last updated: March 24, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: SR58611A
Drug: escitalopram
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in Hamilton Depression Rating scale (HAM-D) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 510
Study Start Date: January 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432614

Locations
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Estonia
Sanofi-Aventis Administrative Office
Tatari, Estonia
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
India
Sanofi-Aventis Administrative Office
Mumbai, India
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Morocco
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Tunisia
Sanofi-Aventis Administrative Office
Megrine, Tunisia
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00432614     History of Changes
Other Study ID Numbers: EFC6224, EudraCT 2006-004146-16
Study First Received: February 7, 2007
Last Updated: March 24, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Sanofi:
Mental Disorder
Mood Disorder
Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Dexetimide
Citalopram
Amibegron
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on October 19, 2014