Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder (ALBERIO)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: SR58611A; Drug: escitalopram; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432614

EudraCT 2006-004146-16

EFC6224

Details and patient eligibility

About

The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.

The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.

Enrollment: 510 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score => 30

Exclusion criteria

• Patient is at immediate risk for suicidal behavior
• Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
• Patients with a current depressive episode secondary to a general medical disorder
• Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
• Patients with severe or unstable concomitant medical conditions
• Pregnant, breastfeeding, or likely to become pregnant during the study
• Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram

The investigator will evaluate whether there are other reasons why a patient may not participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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510 participants in 3 patient groups, including a placebo group

Group 1

Experimental group

Description:

SR58611A 350mg twice daily with escitalopram 10mg once daily

Treatment:

Drug: SR58611A

Drug: escitalopram

Group 2

Active Comparator group

Description:

placebo with escitalopram 10mg once daily

Treatment:

Drug: escitalopram

Group 3

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo