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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Escitalopram; Drug: Placebo (for SSR411298); Drug: SSR411298

Study type: Interventional

Funder types: Industry

Identifiers

NCT00822744

DFI10560

2008-001718-26 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 527 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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527 participants in 5 patient groups, including a placebo group

SSR411298 10 mg

Experimental group

Description:

SSR411298 10 mg, one capsule once daily for 8 weeks

Treatment:

Drug: SSR411298

SSR411298 50 mg

Experimental group

Description:

SSR411298 50 mg, one capsule once daily for 8 weeks

Treatment:

Drug: SSR411298

SSR411298 200 mg

Experimental group

Description:

SSR411298 200 mg, one capsule once daily for 8 weeks

Treatment:

Drug: SSR411298

Escitalopram 10 mg

Active Comparator group

Description:

Escitalopram 10 mg, one capsule once daily for 8 weeks

Treatment:

Drug: Escitalopram

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (for SSR411298)