Clinical Trials Logo
  1. Home
  2. Major Depression
  3. NCT01034995
  4. Details
NCT01034995 Clinical Trial

A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder

Major Depression Clinical Trial

— AGATE  

Official title:
An Eight-week, Multinational, Multicenter, Double-blind, Active- and Placebo-controlled Clinical Trial Evaluating the Efficacy and Tolerability of Three Fixed Doses of SSR125543 (20 mg Daily, 50 mg Daily and 100 mg Daily) in Outpatients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01034995
Other study ID # DFI5687
Secondary ID 2009-010339-42
Status Completed
Phase Phase 2
First received December 17, 2009
Last updated April 13, 2011
Start date February 2010
Est. completion date March 2011

Study information
Verified date April 2011
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

Primary Objective:

- To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Objectives:

- To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder

- To evaluate plasma concentrations of SSR125543

Description:

This duration of this trial is 11 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 580
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion criteria:

- Patients with a diagnosis of major depressive disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).

Exclusion criteria:

- Inpatient hospitalization at screening

- Symptoms of depression present for <30 days or >2 years

- Significant suicide risk

- Mild depression as measured by standard clinical research scales

- History of failure to respond to antidepressant treatment

- Other psychiatric conditions that could obscure the results of the study

- For women of child-bearing potential, the unwillingness to use highly effective means of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SSR125543
Pharmaceutical form: capsule Route of administration: oral
• escitalopram
Pharmaceutical form: encapsulated tablets Route of administration: oral
• placebo
Pharmaceutical form: capsule Route of administration: oral

Locations
Country Name City State
Belgium Sanofi-Aventis Investigational Site Number 056002 Asse
Belgium Sanofi-Aventis Investigational Site Number 056003 Bruxelles
Belgium Sanofi-Aventis Investigational Site Number 056001 Liège
Canada Sanofi-Aventis Investigational Site Number 124011 Burlington
Canada Sanofi-Aventis Investigational Site Number 124012 Chatham
Canada Sanofi-Aventis Investigational Site Number 124004 Edmonton
Canada Sanofi-Aventis Investigational Site Number 124003 Gatineau
Canada Sanofi-Aventis Investigational Site Number 124001 Kelowna
Canada Sanofi-Aventis Investigational Site Number 124006 Mississauga
Canada Sanofi-Aventis Investigational Site Number 124008 Penticton
Canada Sanofi-Aventis Investigational Site Number 124007 Sherbrooke
Canada Sanofi-Aventis Investigational Site Number 124009 Toronto
Chile Sanofi-Aventis Investigational Site Number 152001 Santiago
Chile Sanofi-Aventis Investigational Site Number 152002 Santiago
Chile Sanofi-Aventis Investigational Site Number 152003 Santiago
Chile Sanofi-Aventis Investigational Site Number 152004 Santiago
Chile Sanofi-Aventis Investigational Site Number 152005 Santiago
Chile Sanofi-Aventis Investigational Site Number 152006 Santiago
Chile Sanofi-Aventis Investigational Site Number 152007 Valparaiso
Chile Sanofi-Aventis Investigational Site Number 152008 Vina Del Mar
Estonia Sanofi-Aventis Investigational Site Number 233001 Tallinn
Estonia Sanofi-Aventis Investigational Site Number 233002 Tallinn
Estonia Sanofi-Aventis Investigational Site Number 233004 Tallinn
Estonia Sanofi-Aventis Investigational Site Number 233003 Tartu
Finland Sanofi-Aventis Investigational Site Number 246001 Helsinki
Finland Sanofi-Aventis Investigational Site Number 246003 Helsinki
Finland Sanofi-Aventis Investigational Site Number 246005 Järvenpää
Finland Sanofi-Aventis Investigational Site Number 246002 Tampere
Finland Sanofi-Aventis Investigational Site Number 246004 Turku
France Sanofi-Aventis Investigational Site Number 250008 Arcachon
France Sanofi-Aventis Investigational Site Number 250007 Dole
France Sanofi-Aventis Investigational Site Number 250006 Elancourt
France Sanofi-Aventis Investigational Site Number 250001 Grenoble
France Sanofi-Aventis Investigational Site Number 250003 Montpellier Cedex 05
France Sanofi-Aventis Investigational Site Number 250005 Nimes Cedex 9
France Sanofi-Aventis Investigational Site Number 250004 Orvault
France Sanofi-Aventis Investigational Site Number 250002 Toulouse
Germany Sanofi-Aventis Investigational Site Number 276008 Achim
Germany Sanofi-Aventis Investigational Site Number 276002 Berlin
Germany Sanofi-Aventis Investigational Site Number 276004 Dresden
Germany Sanofi-Aventis Investigational Site Number 276005 Leipzig
Germany Sanofi-Aventis Investigational Site Number 276006 Mannheim
Germany Sanofi-Aventis Investigational Site Number 276007 München
Germany Sanofi-Aventis Investigational Site Number 276001 Schwerin
Germany Sanofi-Aventis Investigational Site Number 276003 Würzburg
Netherlands Sanofi-Aventis Investigational Site Number 528001 Den Haag
Russian Federation Sanofi-Aventis Investigational Site Number 643006 Moscow
Russian Federation Sanofi-Aventis Investigational Site Number 643005 Nizhny Novgorod
Russian Federation Sanofi-Aventis Investigational Site Number 643008 Rostov-Na-Donu
Russian Federation Sanofi-Aventis Investigational Site Number 643010 Saint-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643004 Samara
Russian Federation Sanofi-Aventis Investigational Site Number 643007 Smolensk
Russian Federation Sanofi-Aventis Investigational Site Number 643002 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643003 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643009 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643011 St-Petersburg
Russian Federation Sanofi-Aventis Investigational Site Number 643001 St.-Petersburg
Slovakia Sanofi-Aventis Investigational Site Number 703102 Bratislava
Slovakia Sanofi-Aventis Investigational Site Number 703101 Bratislava 2
Slovakia Sanofi-Aventis Investigational Site Number 703104 Michalovce
Slovakia Sanofi-Aventis Investigational Site Number 703105 Rimavska Sobota
Slovakia Sanofi-Aventis Investigational Site Number 703103 Roznava
South Africa Sanofi-Aventis Investigational Site Number 710001 Cape Town
South Africa Sanofi-Aventis Investigational Site Number 710005 Cape Town
South Africa Sanofi-Aventis Investigational Site Number 710006 Centurion
South Africa Sanofi-Aventis Investigational Site Number 710002 Durban
South Africa Sanofi-Aventis Investigational Site Number 710003 Pretoria
South Africa Sanofi-Aventis Investigational Site Number 710004 Somerset West
Sweden Sanofi-Aventis Investigational Site Number 752004 Linköping
Sweden Sanofi-Aventis Investigational Site Number 752002 Lund
Sweden Sanofi-Aventis Investigational Site Number 752003 Malmö
Sweden Sanofi-Aventis Investigational Site Number 752005 Stockholm
Sweden Sanofi-Aventis Investigational Site Number 752001 Uppsala

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  Canada,  Chile,  Estonia,  Finland,  France,  Germany,  Netherlands,  Russian Federation,  Slovakia,  South Africa,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score 8 weeks No
Secondary Change from baseline in HAM-D depressed mood item 8 weeks No
Secondary Change from baseline in HAM-D responders (50% improvement) 8 weeks No
Secondary Changes from baseline in the HAM-D core and factor scores 8 weeks No
Secondary Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score 8 weeks No
Secondary Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score 8 weeks No
See also
  Status Clinical Trial Phase
Completed NCT03062150 - Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression N/A
Completed NCT04352101 - Bupropion Versus Escitalopram on Reward Circuitry and Motivational Deficits Phase 4
Completed NCT02855918 - Blood Biomarkers in Suicidal Behaviour N/A
Recruiting NCT03039387 - Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients N/A
Recruiting NCT02213016 - Effectiveness of Repetitive Transcranial Magnetic Stimulation in Depressed Patients Phase 4
Completed NCT01683539 - Understanding How Cognitive Remediation Works N/A
Completed NCT01636791 - CBT Versus a Return to Work Intervention for Patients With Common Mental Illness in Primary Care Phase 3
Recruiting NCT02237937 - Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene Phase 4
Completed NCT01201148 - Open Pilot Trial of TES for Depression Phase 2
Completed NCT00953108 - Quetiapine Prolong, Escitalopram and Hypothalamic-pituitary-adrenocortical (HPA) Axis Activity in Depressed Patients Phase 3
Terminated NCT01244711 - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines Phase 4
Completed NCT00711737 - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months N/A
Completed NCT00806143 - Bilateral Versus Monolateral Repetitive Transcranial Stimulation in Depression Phase 4
Terminated NCT00695552 - The Effect of Exercise on Depressive Symptoms in Unmedicated Patients N/A
Completed NCT00482482 - Yoga in Unipolar and Bipolar Disorders N/A
Completed NCT00466323 - The Effectiveness of FMPO in Improving the Quality of Care for Persons With Severe Mental Illness. N/A
Completed NCT00532480 - Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine Phase 4
Completed NCT00616759 - The Effect on Cognition of Terminating ECT Induced Seizures With Propofol N/A
Recruiting NCT00209807 - Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder Phase 4
Completed NCT00167310 - Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation Phase 2