Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00855530

Purpose

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.

Condition	Intervention	Phase
Major Depressive Disorders	Drug: amibegron (SR58611A)	Phase III

MedlinePlus related topics: Depression

Drug Information available for: SR 58611A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
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.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Clinical monitoring of adverse events (AEs), laboratory parameters, vital signs, physical examinations, and physician withdrawal checklists [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]

Enrollment:	527
Study Start Date:	September 2005
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: amibegron (SR58611A) oral administration of 300 mg twice daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855530

Locations

Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
Hong Kong
Sanofi-Aventis Administrative Office
Causeway Bay, Hong Kong
Morocco
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Tunisia
Sanofi-Aventis Administrative Office
Megrine, Tunisia

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	LTS4848
Study First Received:	March 3, 2009
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00855530 History of Changes
Health Authority:	Spain: Ethics Committee

Keywords provided by Sanofi-Aventis:

Depression

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Adrenergic beta-Agonists
Adrenergic Agents
Mental Disorders
SR 58611A

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Adrenergic Agonists
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Depression
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Adrenergic Agents
Physiological Effects of Drugs
Depressive Disorder, Major

Depressive Disorder
Pharmacologic Actions
Adrenergic Agonists
Behavioral Symptoms
Pathologic Processes
Mental Disorders
SR 58611A
Mood Disorders

ClinicalTrials.gov processed this record on May 06, 2009