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

NCT ID: NCT00336713

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-04-30

Brief Summary

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.

Conditions

Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Saredutant 100 mg

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

Group Type: EXPERIMENTAL

Saredutant (SR48968C)

Intervention Type: DRUG

oral administration (capsules)

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral administration (capsules)

Interventions

Saredutant (SR48968C)

oral administration (capsules)

Intervention Type: DRUG

Placebo

oral administration (capsules)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

SR48968

Identifier Type: -

Identifier Source: secondary_id

EFC5576

Identifier Type: -

Identifier Source: org_study_id