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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.
 
ClinicalTrials.gov Identifier: NCT00432614
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE February 7, 2007
First Posted Date  ICMJE February 8, 2007
Last Update Posted Date March 25, 2009
Study Start Date  ICMJE January 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
Change from baseline in Hamilton Depression Rating scale (HAM-D) total score [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2007)
Change from baseline in Hamilton Depression Rating scale (HAM-D) total score at 8 weeks
Change History Complete list of historical versions of study NCT00432614 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2007)
Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score at 8 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: SR58611A
    oral administration
  • Drug: escitalopram
    oral administration
  • Drug: placebo
    oral administration
Study Arms  ICMJE
  • Experimental: Group 1
    SR58611A 350mg twice daily with escitalopram 10mg once daily
    Interventions:
    • Drug: SR58611A
    • Drug: escitalopram
  • Active Comparator: Group 2
    placebo with escitalopram 10mg once daily
    Intervention: Drug: escitalopram
  • Placebo Comparator: Group 3
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2008)
510
Original Enrollment  ICMJE
 (submitted: February 7, 2007)
500
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Estonia,   Finland,   France,   Germany,   Greece,   India,   Korea, Republic of,   Malaysia,   Morocco,   Taiwan,   Tunisia,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00432614
Other Study ID Numbers  ICMJE EFC6224
EudraCT 2006-004146-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP