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

NCT00336713 | Completed Phase 3 DMC

• 2 other identifiers: EFC5576SR48968
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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

Keywords

depression; antidepressive agents; controlled clinical trial

Outcome Measures

Primary Outcomes (1)

• The time to relapse of depressive symptoms (in days) during the Maintenance Phase.

  minimum 24 weeks and maximum 52 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Saredutant 100 mg

EXPERIMENTAL

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

Drug: Saredutant (SR48968C)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Saredutant (SR48968C) DRUG

oral administration (capsules)

Saredutant 100 mg

Placebo DRUG

oral administration (capsules)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

SR 48968

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 14, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 13, 2016

Record last verified: 2016-04

Locations

US (1)