An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder - Full Text View

Purpose

The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate plasma concentrations of saredutant and SR49596 (inactive metabolite).To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.

Condition	Intervention	Phase
Depressive Disorder	Drug: saredutant (SR48968) Drug: placebo Drug: escitalopram	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	An Eight-week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Changes from baseline to Day 56 in the HAM-D depressed mood item, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Clinical Global Impression (CGI) Severity of Illness scores. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	393
Study Start Date:	December 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 oral administration 100 mg once daily	Drug: saredutant (SR48968) oral administration (capsules)
Placebo Comparator: 2 oral administration	Drug: placebo oral administration (capsules)
Active Comparator: 3 oral administration 10 mg once daily	Drug: escitalopram oral administration (capsules)

Eligibility

Ages Eligible for Study:	60 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of major depressive disorder, recurrent, as defined by 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:

Total score of less than 23 on the MADRS.
HAM-D total score less than 17.
Duration of the current depressive episode less than 1 month or greater than 2 years.
Patients with an Mini Mental State Examination score of less than 23.
Patients with a history or presence of bipolar disorders or psychotic disorders.
Patients with alcohol/substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, monoamine oxidase inhibitors within 4 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week.

The investigator will evaluate whether there are other reasons why a patient may not participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415142

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
France
Sanofi-Aventis Administrative Office
Paris, France
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi

More Information

No publications provided

Responsible Party:	Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00415142 History of Changes
Other Study ID Numbers:	EFC5574
Study First Received:	December 21, 2006
Last Updated:	July 25, 2011
Health Authority:	United States: Food and Drug Administration Mexico: Ministry of Health Russia: Ministry of Health of the Russian Federation Croatia: Ministry of Health and Social Care

Keywords provided by Sanofi:

Depression
Major depressive disorders
Controlled clinical trial

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
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 May 16, 2013