Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD).

Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorders	Drug: amibegron (SR58611A); Drug: placebo; Drug: paroxetine	Phase 3

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	306 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.
Study Start Date :	September 2003
Actual Primary Completion Date :	October 2004
Actual Study Completion Date :	December 2004

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1	Drug: amibegron (SR58611A); oral administration of 2x 700 mg/day in 12h intervals
Placebo Comparator: 2	Drug: placebo; oral administration in 12h intervals
Active Comparator: 3; paroxetine	Drug: paroxetine; oral administration of 20 mg/day

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. change from baseline of the total score of the HAM-D 17 items [ Time Frame: 6 weeks ]

Secondary Outcome Measures :

1. HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores [ Time Frame: 6 weeks ]
2. Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 6 weeks ]
3. clinical global impression (CGI) severity and improvement scores [ Time Frame: 6 weeks ]
4. patient global impression (PGI) improvement score [ Time Frame: 6 weeks ]
5. social and occupational functioning assessment scale (SOFAS) score [ Time Frame: 6 weeks ]
6. AEs, Arizona Sexual Experience Scale (ASEX), [ Time Frame: 6 weeks ]
7. laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight [ Time Frame: 6 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
• patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
• the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807

Sponsors and Collaborators

Sanofi

Investigators

Study Director:	ICD CSD	Sanofi

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00825019 History of Changes
Other Study ID Numbers:	EFC5379
First Posted:	January 19, 2009
Last Update Posted:	March 25, 2009
Last Verified:	March 2009

Keywords provided by Sanofi:

Depression

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms; Paroxetine; Amibegron; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action	Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents