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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder

Treatments: Drug: saredutant (SR48968); Drug: escitalopram; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00415142

EFC5574

Details and patient eligibility

About

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.

Enrollment: 393 patients

Sex: All

Ages: 60 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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393 participants in 3 patient groups, including a placebo group

Saredutant 100 mg

Experimental group

Description:

Saredudant100 mg once daily for a maximum of 32 weeks

Treatment:

Drug: saredutant (SR48968)

Escitalopram 10 mg

Active Comparator group

Description:

Escitalopram 10 mg once daily for a maximum of 32 weeks

Treatment:

Drug: escitalopram

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo