An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

527 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-02-28

Brief Summary

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The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale.

Secondary objectives are:

* To evaluate the tolerability and safety of an 8-week treatment with SSR411298 versus placebo in elderly patients with MDD.
* To evaluate the effect of SSR411298 on disability, anxiety, cognitive function, sleep, pain and somatic symptoms related to depression, and bone markers.
* To assess SSR411298 plasma concentrations.
* To assess plasma endocannabinoid concentrations.

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Detailed Description

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The study period for a participants is approximately 10 weeks including a screening up to 1 week, 8-week treatment and 1-week follow-up.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SSR411298 10 mg

SSR411298 10 mg, one capsule once daily for 8 weeks

Group Type EXPERIMENTAL

SSR411298

Intervention Type DRUG

Form: capsule

Route: oral administration with food

SSR411298 50 mg

SSR411298 50 mg, one capsule once daily for 8 weeks

Group Type EXPERIMENTAL

SSR411298

Intervention Type DRUG

Form: capsule

Route: oral administration with food

SSR411298 200 mg

SSR411298 200 mg, one capsule once daily for 8 weeks

Group Type EXPERIMENTAL

SSR411298

Intervention Type DRUG

Form: capsule

Route: oral administration with food

Escitalopram 10 mg

Escitalopram 10 mg, one capsule once daily for 8 weeks

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules)

Route: oral administration with food

Placebo

Placebo (for SSR411298), one capsule once daily for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo (for SSR411298)

Intervention Type DRUG

Form: capsule

Route: oral administration with food

Interventions

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SSR411298

Form: capsule

Route: oral administration with food

Intervention Type DRUG

Escitalopram

Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules)

Route: oral administration with food

Intervention Type DRUG

Placebo (for SSR411298)

Form: capsule

Route: oral administration with food

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elderly patient with recurrent Major Depressive Disorder

Exclusion Criteria

* Duration of current depressive episode greater than 2 years;
* Mild depression as measured by standard clinical research scales;
* Cognitive disturbance;
* Significant suicide risk;
* Other psychiatric conditions that would obscure the results of the study;
* History of failure to respond to antidepressant treatment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No