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Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorders

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

amibegron (SR58611A)

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

patients as defined by Diagnosis and Statistical Manual of Mental Disorders, recurrent episode for at least 1 month prior to entry into the study, and with a total score of > 18 on the Hamilton Depression Rating Scale (HAM-D) 17-items.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Clinical monitoring of adverse events (AEs), laboratory parameters, vital signs, physical examinations, and physician withdrawal checklists

Secondary Outcome Measures

17-item Hamilton Depression rating Scale, Clinical Global Impression, Sheehan Disability Scale, Qol Enjoyment and satisfaction Questionnaire - Short Form,Medical Outcomes Study Short Form, Endicott Work Productivity Scale.

Full Information

NCT ID

NCT00855530

First Posted

March 3, 2009

Last Updated

March 24, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00855530

Brief Title

Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder

Official Title

A Fifty-Two-Week Multicenter, Open-Label, Study Evaluating the Long-Term Safety and Tolerability of SR58611A 350 mg q12 in Patients With Major Depressive Disorder.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary objective: - To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with major depressive disorder (MDD). Secondary objective: - To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with MDD, and to evaluate the efficacy of amibegron in patients with MDD.

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

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

527 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

amibegron (SR58611A)

Intervention Description

oral administration of 300 mg twice daily

Primary Outcome Measure Information:

Title

Clinical monitoring of adverse events (AEs), laboratory parameters, vital signs, physical examinations, and physician withdrawal checklists

Time Frame

54 weeks

Secondary Outcome Measure Information:

Title

Time Frame

54 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients as defined by Diagnosis and Statistical Manual of Mental Disorders, recurrent episode for at least 1 month prior to entry into the study, and with a total score of > 18 on the Hamilton Depression Rating Scale (HAM-D) 17-items.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name