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

Primary Purpose

Major Depressive Disorders

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

amibegron (SR58611A)

placebo

paroxetine

About this trial

This is an interventional treatment trial for Major Depressive Disorders focused on measuring Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Arm Description

paroxetine

Outcomes

Primary Outcome Measures

change from baseline of the total score of the HAM-D 17 items

Secondary Outcome Measures

HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores

Montgomery-Asberg Depression Rating Scale (MADRS) total score

clinical global impression (CGI) severity and improvement scores

patient global impression (PGI) improvement score

social and occupational functioning assessment scale (SOFAS) score

AEs, Arizona Sexual Experience Scale (ASEX),

laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight

Full Information

NCT ID

NCT00825019

First Posted

January 16, 2009

Last Updated

March 24, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00825019

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

October 2004 (Actual)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorders

Keywords

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

306 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Arm Description

paroxetine

Intervention Type

Drug

Intervention Name(s)

amibegron (SR58611A)

Intervention Description

oral administration of 2x 700 mg/day in 12h intervals

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral administration in 12h intervals

Intervention Type

Drug

Intervention Name(s)

paroxetine

Intervention Description

oral administration of 20 mg/day

Primary Outcome Measure Information:

Title

change from baseline of the total score of the HAM-D 17 items

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores

Time Frame

6 weeks

Title

Montgomery-Asberg Depression Rating Scale (MADRS) total score

Time Frame

6 weeks

Title

clinical global impression (CGI) severity and improvement scores

Time Frame

6 weeks

Title

patient global impression (PGI) improvement score

Time Frame

6 weeks

Title

social and occupational functioning assessment scale (SOFAS) score

Time Frame

6 weeks

Title

AEs, Arizona Sexual Experience Scale (ASEX),

Time Frame

6 weeks

Title

laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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