A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder

Treatments: Drug: Placebo; Drug: Saredutant (SR48968C)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00336713

SR48968

EFC5576

Details and patient eligibility

About

The purpose of the study is to evaluate the long-term efficacy and safety of Saredutant in patients with depression. The primary objective is to evaluate the efficacy and safety of Saredutant 100 mg once daily compared to placebo in the prevention of relapse of depressive symptoms in outpatients with major depressive disorder who achieved an initial response to 12 weeks of open-label treatment with Saredutant.

Enrollment: 430 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Total score of 28 or less on the Montgomery and Asberg Depression Rating Scale (MADRS).
• Clinical Global Impression (CGI) severity score of less than 4.
• Duration of the current depressive episode less than 2 months or greater than 2 years.
• Elderly patients with a Mini-Mental State Examination (MMSE) total score <25.
• Patients with a history or presence of bipolar disorders or psychotic disorders.
• Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
• Benzodiazepine or sedative-hypnotic use greater than 2 days per week during the month prior to entry into the Acute Phase.
• Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, Monoamine oxidase inhibitors (MAOIs) within 2 weeks, other antidepressant 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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430 participants in 2 patient groups, including a placebo group

Saredutant 100 mg

Experimental group

Description:

Saredutant 100 mg once daily in the morning for a maximum of 64 weeks

Treatment:

Drug: Saredutant (SR48968C)

Placebo

Placebo Comparator group

Description:

Placebo for Saredutant once daily in the morning during the maintenance phase for a maximum of 52 weeks

Treatment:

Drug: Placebo