A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT01034995

Purpose

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

Condition	Intervention	Phase
Major Depression	Drug: SSR125543 Drug: escitalopram Drug: placebo	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in HAM-D depressed mood item [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in HAM-D responders (50% improvement) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Changes from baseline in the HAM-D core and factor scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	580
Study Start Date:	February 2010
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SSR125543 20 mg 1 capsule of SSR125543 20 mg + 1 capsule of placebo	Drug: SSR125543 Pharmaceutical form: capsule Route of administration: oral
Experimental: SSR125543 50 mg 1 capsule of SSR125543 50 mg + 1 capsule of placebo	Drug: SSR125543 Pharmaceutical form: capsule Route of administration: oral
Experimental: SSR125543 100 mg 2 capsules of SSR125543 50 mg	Drug: SSR125543 Pharmaceutical form: capsule Route of administration: oral
Active Comparator: escitalopram 10 mg 1 capsule of escitalopram 10 mg + 1 capsule of placebo	Drug: escitalopram Pharmaceutical form: encapsulated tablets Route of administration: oral
Placebo Comparator: placebo 2 capsules of placebo	Drug: placebo Pharmaceutical form: capsule Route of administration: oral

Detailed Description:

This duration of this trial is 11 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034995

Show 73 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT01034995 History of Changes
Other Study ID Numbers:	DFI5687, 2009-010339-42
Study First Received:	December 17, 2009
Last Updated:	April 13, 2011
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
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
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012