NCT00415142|CompletedPhase 3DMC

An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder

An Eight-week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients With Major Depressive Disorder

Sanofi ClinicalTrials.gov

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1 other identifier

EFC5574

Study Type

interventional

Target

393

Locations

8 countries

Sites

Timeline

RegisteredDec 2006

StartedDec 2006

CompletionFeb 2008

Brief Summary

The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.

Trial Health

On Track

Trial Health Score

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

Enrollment

393

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2006

Shorter than P25 for phase_3

Geographic Reach

8 countries

8 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

1.2 years study duration

Study Start

First participant enrolled

December 1, 2006

Completed

20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed

1.1 years 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

May 24, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

December 21, 2006

Last Update Submit

April 25, 2016

Conditions

Depressive Disorder

Keywords

DepressionMajor depressive disordersControlled clinical trial

Outcome Measures

Primary Outcomes (1)

Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Day 56

Secondary Outcomes (3)

Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.
Day 56
Change from baseline to Day 56 in the HAM-D depressed mood item score
Day 56
Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Day 56

Study Arms (3)

Saredutant 100 mg

EXPERIMENTAL

Saredudant100 mg once daily for a maximum of 32 weeks

Drug: saredutant (SR48968)

Escitalopram 10 mg

ACTIVE COMPARATOR

Escitalopram 10 mg once daily for a maximum of 32 weeks

Drug: escitalopram

Placebo

PLACEBO COMPARATOR

Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase

Drug: placebo

Interventions

saredutant (SR48968)DRUG

oral administration (capsules)

Saredutant 100 mg

placeboDRUG

oral administration (capsules)

Placebo

escitalopramDRUG

oral administration (capsules)

Escitalopram 10 mg

Eligibility Criteria

Age60 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).

You may not qualify if:

Total score of less than 23 on the MADRS.
HAM-D total score less than 17.
Duration of the current depressive episode less than 1 month or greater than 2 years.
Patients with an Mini Mental State Examination score of less than 23.
Patients with a history or presence of bipolar disorders or psychotic disorders.
Patients with alcohol/substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, monoamine oxidase inhibitors within 4 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week.
The investigator will evaluate whether there are other reasons why a patient may not participate

Contact the study team to confirm eligibility.