Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine
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ClinicalTrials.gov Identifier: NCT00825019 |
Recruitment Status :
Completed
First Posted : January 19, 2009
Last Update Posted : March 25, 2009
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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 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 |

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 |
- change from baseline of the total score of the HAM-D 17 items [ Time Frame: 6 weeks ]
- HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores [ Time Frame: 6 weeks ]
- Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 6 weeks ]
- clinical global impression (CGI) severity and improvement scores [ Time Frame: 6 weeks ]
- patient global impression (PGI) improvement score [ Time Frame: 6 weeks ]
- social and occupational functioning assessment scale (SOFAS) score [ Time Frame: 6 weeks ]
- AEs, Arizona Sexual Experience Scale (ASEX), [ Time Frame: 6 weeks ]
- laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight [ Time Frame: 6 weeks ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825019
United States, New Jersey | |
Sanofi-Aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 |
Study Director: | ICD CSD | Sanofi |
Responsible Party: | ICD Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00825019 |
Other Study ID Numbers: |
EFC5379 |
First Posted: | January 19, 2009 Key Record Dates |
Last Update Posted: | March 25, 2009 |
Last Verified: | March 2009 |
Depression |
Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders 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 |