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

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 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Sanofi:

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
Experimental: 1	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

Investigators

Study Director:

ICD CSD

Sanofi

More Information

No publications provided

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

Keywords provided by Sanofi:

Depression

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
SR 58611A

Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013