An Eight-Week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00629551

Purpose

The main purpose of this study is to evaluate the efficacy of saredutant 100mg or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).

Condition	Intervention	Phase
Depressive Disorder, Major	Drug: saredutant (SR48968) Drug: paroxetine Drug: placebo	Phase III

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate SR 48968

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	An Eight-Week, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Saredutant (100 mg and 30 mg) Once Daily in Combination With Paroxetine 20 mg Once Daily Compared to Saredutant Placebo in Combination With Paroxetine 20 mg Once Daily in Patients With Major Depressive Disorder

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change from baseline in Hamilton Depression Rating Scale total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in the Changes in Sexual Functioning Questionnaire total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in the Clinical Global Impression severity of illness score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	820
Study Start Date:	February 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental combined saredutant 100mg and paroxetine 20mg	Drug: saredutant (SR48968) once daily Drug: paroxetine once daily
2: Experimental combined saredutant 30mg and paroxetine 20mg	Drug: saredutant (SR48968) once daily Drug: paroxetine once daily
3: Active Comparator paroxetine 20mg	Drug: paroxetine once daily
4: Placebo Comparator	Drug: placebo once daily

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Outpatients with recurrent Major Depressive Disorder

Exclusion Criteria:

Symptoms of current depressive episode for less than 30 days or more than 2 years
Mild depression, as measured by standard clinical research scales
Significant suicide risk
Lack of sexual activity (including masturbation)
Other psychiatric conditions that would obscure the results of the study
History of failure to respond to antidepressant treatment
Pregnancy or breast-feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629551

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Estonia
Sanofi-Aventis Administrative Office
Tallinn, Estonia
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC10438, EudraCT 2007-003863-31
Study First Received:	February 26, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00629551
Health Authority:	United States: Food and Drug Administration; Chile: Instituto de Salud Publica de Chile; Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Sanofi-Aventis:

Major Depressive Disorder
Depression
Major Depressive Episode
Antidepressant

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Paroxetine
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors

Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009