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

NCT01034995 | Completed Phase 2 DMC

• 2 other identifiers: DFI56872009-010339-42
• Study Type: interventional
• Target: 580
• Locations: 12 countries
• Sites: 73

Brief 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

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

• Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score

  8 weeks

Secondary Outcomes (5)

• Change from baseline in HAM-D depressed mood item

  8 weeks

• Change from baseline in HAM-D responders (50% improvement)

  8 weeks

• Changes from baseline in the HAM-D core and factor scores

  8 weeks

• Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score

  8 weeks

• Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score

  8 weeks

Study Arms (5)

SSR125543 20 mg

EXPERIMENTAL

1 capsule of SSR125543 20 mg + 1 capsule of placebo

Drug: SSR125543

SSR125543 50 mg

EXPERIMENTAL

1 capsule of SSR125543 50 mg + 1 capsule of placebo

Drug: SSR125543

SSR125543 100 mg

EXPERIMENTAL

2 capsules of SSR125543 50 mg

Drug: SSR125543

escitalopram 10 mg

ACTIVE COMPARATOR

1 capsule of escitalopram 10 mg + 1 capsule of placebo

Drug: escitalopram

placebo

PLACEBO COMPARATOR

2 capsules of placebo

Drug: placebo

Interventions

SSR125543 DRUG

Pharmaceutical form: capsule Route of administration: oral

SSR125543 100 mg; SSR125543 20 mg; SSR125543 50 mg

escitalopram DRUG

Pharmaceutical form: encapsulated tablets Route of administration: oral

escitalopram 10 mg

placebo DRUG

Pharmaceutical form: capsule Route of administration: oral

placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (73)

Sanofi-Aventis Investigational Site Number 056002

Asse, 1730, Belgium

Location

Sanofi-Aventis Investigational Site Number 056003

Brussels, 1180, Belgium

Location

Sanofi-Aventis Investigational Site Number 056001

Liège, 4000, Belgium

Location

Sanofi-Aventis Investigational Site Number 124011

Burlington, L7R 4E2, Canada

Location

Sanofi-Aventis Investigational Site Number 124012

Chatham, N7M 1B7, Canada

Location

Sanofi-Aventis Investigational Site Number 124004

Edmonton, T6L 5X8, Canada

Location

Sanofi-Aventis Investigational Site Number 124003

Gatineau, J9A 1K7, Canada

Location

Sanofi-Aventis Investigational Site Number 124001

Kelowna, V1Y 1Z9, Canada

Location

Sanofi-Aventis Investigational Site Number 124006

Mississauga, L5M 4N4, Canada

Location

Sanofi-Aventis Investigational Site Number 124008

Penticton, V2A 4M4, Canada

Location

Sanofi-Aventis Investigational Site Number 124007

Sherbrooke, J1V 4J7, Canada

Location

Sanofi-Aventis Investigational Site Number 124009

Toronto, M3H 5S4, Canada

Location

Sanofi-Aventis Investigational Site Number 152001

Santiago, 750-0710, Chile

Location

Sanofi-Aventis Investigational Site Number 152002

Santiago, 751-0041, Chile

Location

Sanofi-Aventis Investigational Site Number 152003

Santiago, 756-0356, Chile

Location

Sanofi-Aventis Investigational Site Number 152005

Santiago, 8053095, Chile

Location

Sanofi-Aventis Investigational Site Number 152006

Santiago, 890-0085, Chile

Location

Sanofi-Aventis Investigational Site Number 152004

Santiago, Chile

Location

Sanofi-Aventis Investigational Site Number 152007

Valparaíso, 236-0002, Chile

Location

Sanofi-Aventis Investigational Site Number 152008

Viña del Mar, Chile

Location

Sanofi-Aventis Investigational Site Number 233001

Tallinn, 10613, Estonia

Location

Sanofi-Aventis Investigational Site Number 233002

Tallinn, 11911, Estonia

Location

Sanofi-Aventis Investigational Site Number 233004

Tallinn, 13419, Estonia

Location

Sanofi-Aventis Investigational Site Number 233003

Tartu, 50406, Estonia

Location

Sanofi-Aventis Investigational Site Number 246001

Helsinki, 00260, Finland

Location

Sanofi-Aventis Investigational Site Number 246003

Helsinki, 00530, Finland

Location

Sanofi-Aventis Investigational Site Number 246005

Jarvenpaa, 04400, Finland

Location

Sanofi-Aventis Investigational Site Number 246002

Tampere, 33200, Finland

Location

Sanofi-Aventis Investigational Site Number 246004

Turku, 20100, Finland

Location

Sanofi-Aventis Investigational Site Number 250008

Arcachon, 33120, France

Location

Sanofi-Aventis Investigational Site Number 250007

Dole, 39100, France

Location

Sanofi-Aventis Investigational Site Number 250006

Élancourt, 78990, France

Location

Sanofi-Aventis Investigational Site Number 250001

Grenoble, 38043, France

Location

Sanofi-Aventis Investigational Site Number 250003

Montpellier, 34295, France

Location

Sanofi-Aventis Investigational Site Number 250005

Nîmes, 30029, France

Location

Sanofi-Aventis Investigational Site Number 250004

Orvault, 44700, France

Location

Sanofi-Aventis Investigational Site Number 250002

Toulouse, 31000, France

Location

Sanofi-Aventis Investigational Site Number 276008

Achim, 28832, Germany

Location

Sanofi-Aventis Investigational Site Number 276002

Berlin, 10629, Germany

Location

Sanofi-Aventis Investigational Site Number 276004

Dresden, 01307, Germany

Location

Sanofi-Aventis Investigational Site Number 276005

Leipzig, 04107, Germany

Location

Sanofi-Aventis Investigational Site Number 276006

Mannheim, 68159, Germany

Location

Sanofi-Aventis Investigational Site Number 276007

München, 80333, Germany

Location

Sanofi-Aventis Investigational Site Number 276001

Schwerin, 19053, Germany

Location

Sanofi-Aventis Investigational Site Number 276003

Würzburg, 97070, Germany

Location

Sanofi-Aventis Investigational Site Number 528001

The Hague, 2512 VA, Netherlands

Location

Sanofi-Aventis Investigational Site Number 643006

Moscow, 117152, Russia

Location

Sanofi-Aventis Investigational Site Number 643005

Nizhny Novgorod, 603155, Russia

Location

Sanofi-Aventis Investigational Site Number 643008

Rostov-on-Don, 344010, Russia

Location

Sanofi-Aventis Investigational Site Number 643001

Saint Petersburg, 190005, Russia

Location

Sanofi-Aventis Investigational Site Number 643009

Saint Petersburg, 190121, Russia

Location

Sanofi-Aventis Investigational Site Number 643010

Saint Petersburg, 190121, Russia

Location

Sanofi-Aventis Investigational Site Number 643011

Saint Petersburg, 191119, Russia

Location

Sanofi-Aventis Investigational Site Number 643003

Saint Petersburg, 192019, Russia

Location

Sanofi-Aventis Investigational Site Number 643002

Saint Petersburg, 194044, Russia

Location

Sanofi-Aventis Investigational Site Number 643004

Samara, 443016, Russia

Location

Sanofi-Aventis Investigational Site Number 643007

Smolensk, 214019, Russia

Location

Sanofi-Aventis Investigational Site Number 703102

Bratislava, 81107, Slovakia

Location

Sanofi-Aventis Investigational Site Number 703101

Bratislava, 82606, Slovakia

Location

Sanofi-Aventis Investigational Site Number 703104

Michalovce, 07101, Slovakia

Location

Sanofi-Aventis Investigational Site Number 703105

Rimavská Sobota, 979 12, Slovakia

Location

Sanofi-Aventis Investigational Site Number 703103

Rožňava, 04801, Slovakia

Location

Sanofi-Aventis Investigational Site Number 710005

Cape Town, 7530, South Africa

Location

Sanofi-Aventis Investigational Site Number 710001

Cape Town, 7646, South Africa

Location

Sanofi-Aventis Investigational Site Number 710006

Centurion, 0157, South Africa

Location

Sanofi-Aventis Investigational Site Number 710002

Durban, 3629, South Africa

Location

Sanofi-Aventis Investigational Site Number 710003

Pretoria, 0181, South Africa

Location

Sanofi-Aventis Investigational Site Number 710004

Somerset West, 7130, South Africa

Location

Sanofi-Aventis Investigational Site Number 752004

Linköping, 582 16, Sweden

Location

Sanofi-Aventis Investigational Site Number 752002

Lund, 223 61, Sweden

Location

Sanofi-Aventis Investigational Site Number 752003

Malmo, 211 52, Sweden

Location

Sanofi-Aventis Investigational Site Number 752005

Stockholm, 112 34, Sweden

Location

Sanofi-Aventis Investigational Site Number 752001

Uppsala, 753 10, Sweden

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

SSR125543; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 18, 2009
• Study Start: February 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 14, 2011

Record last verified: 2011-04

Locations

NL (1); ZA (6); FI (5); RU (11); SE (5); SL (5); FR (8); DE (8); CA (9); BE (3); CL (8); ES (4)