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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

527

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Sep 2005

Geographic Reach

11 countries

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

September 1, 2005

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed

1.7 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed

Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

1.8 years

First QC Date

March 3, 2009

Last Update Submit

March 24, 2009

Conditions

Major Depressive Disorders

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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.
54 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: amibegron (SR58611A)

Interventions

amibegron (SR58611A)DRUG

oral administration of 300 mg twice daily

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Contact the study team to confirm eligibility.