NCT00432614|CompletedPhase 3

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

ALBERIO

A Multi-National, Multi-Center, DB, Placebo-Controlled, Parallel Group, Fixed Dose Efficacy & Safety Study of SR58611A 350 mg Twice Daily vs. Placebo in Adults With Major Depressive Disorder on Concomitant Treatment With Escitalopram 10mg/d

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC6224EudraCT 2006-004146-16

Study Type

interventional

Target

510

Locations

12 countries

Sites

Timeline

RegisteredFeb 2007

StartedJan 2007

CompletionFeb 2008

Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

510

participants targeted

Target at P50-P75 for phase_3 major-depressive-disorder

Timeline

Completed

Started Jan 2007

Shorter than P25 for phase_3 major-depressive-disorder

Geographic Reach

12 countries

12 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

January 1, 2007

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed

Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

1.1 years

First QC Date

February 7, 2007

Last Update Submit

March 24, 2009

Conditions

Major Depressive Disorder

Keywords

Mental DisorderMood DisorderDepressive Disorder

Outcome Measures

Primary Outcomes (1)

Change from baseline in Hamilton Depression Rating scale (HAM-D) total score
8 weeks

Secondary Outcomes (1)

Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score
8 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

SR58611A 350mg twice daily with escitalopram 10mg once daily

Drug: SR58611ADrug: escitalopram

Group 2

ACTIVE COMPARATOR

placebo with escitalopram 10mg once daily

Drug: escitalopram

Group 3

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

SR58611ADRUG

oral administration

Group 1

escitalopramDRUG

oral administration

Group 1Group 2

placeboDRUG

oral administration

Group 3

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.