An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder

April 25, 2016 updated by: Sanofi

An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Patients With Generalized Anxiety Disorder

The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

365

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Sanofi-Aventis Administrative Office
  • Canada
      • Laval, Canada
        • Sanofi-Aventis Administrative Office
  • Finland
      • Helsinki, Finland
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Italy
      • Milano, Italy
        • Sanofi-Aventis Administrative Office
  • Sweden
      • Stockholm, Sweden
        • Sanofi-Aventis Administrative Office
  • Turkey
      • Istanbul, Turkey
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of generalized anxiety disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) Plus Generalized Anxiety Disorder module.

Exclusion Criteria:

  • Total score of less than 22 on the HAM-A.
  • Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 18.
  • Patients with a current history (within 6 months) of major depressive disorder or 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.
  • Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine Oxidase Inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.

The investigator will evaluate whether there are other reasons why a patient may not participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saredutant 100 mg
Saredutant 100 mg once daily in the morning for a maximum of 8 weeks
Drug: Saredutant
oral administration (capsules)
Active Comparator: Escitalopram 10 mg
Escitalopram 10 mg once daily in the morning for a maximum of 8 weeks
Drug: Escitalopram
oral administration (capsules)
Placebo Comparator: Placebo
Placebo for one week during the run in period and for a maximum of 8 weeks during the active period
Drug: Placebo
oral administration (capsules)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
Time Frame: Baseline, Day 56
Baseline, Day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the Clinical Global Impression Severity of Illness score.
Time Frame: Baseline, Day 56
Baseline, Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

December 28, 2006

First Submitted That Met QC Criteria

December 28, 2006

First Posted (Estimate)

December 29, 2006

Study Record Updates

Last Update Posted (Estimate)

May 24, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5583

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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