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

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Major Depressive Disorders

Treatments

Drug: amibegron (SR58611A)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00855530
LTS4848

Details and patient eligibility

About

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.

Enrollment

527 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

527 participants in 1 patient group

1
Experimental group
Treatment:
Drug: amibegron (SR58611A)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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