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Completed

NCT Number: NCT00432614

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Diegem, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SR58611A

Drug

oral administration

Escitalopram

Drug

oral administration

Placebo

Drug

oral administration

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: ALBERIO

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 8, 2007
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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