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

A Multicenter, 24-52-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, and Safety of Saredutant 100 mg Once Daily in the Prevention of Relapse of Depressive Symptoms in Outpatients With Major Depressive Disorder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00336713

Enrollment

430

Registered

2006-06-14

Start date

2006-05-31

Completion date

2008-04-30

Last updated

2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

Keywords

depression, antidepressive agents, controlled clinical trial

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.

Interventions

DRUGSaredutant (SR48968C)

oral administration (capsules)

DRUGPlacebo

oral administration (capsules)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
The time to relapse of depressive symptoms (in days) during the Maintenance Phase.	minimum 24 weeks and maximum 52 weeks

Secondary

Measure	Time frame
Changes from baseline in the CGI Severity of Illness, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Hamilton Anxiety Rating Scale (HAM-A) total and factor scores during the Maintenance Phase.	minimum 24 weeks and maximum 52 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026