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An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: October 19, 2006
Last updated: April 25, 2016
Last verified: April 2016
The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) 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.

Condition Intervention Phase
Generalized Anxiety
Drug: Saredutant
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Efficacy, Safety and Tolerability of Two Fixed Doses (100 and 30 mg Once Daily) of Saredutant in Patients With Generalized Anxiety Disorder

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score. [ Time Frame: 56 days ]

Secondary Outcome Measures:
  • Change from baseline to Day 56 of treatment in the Clinical Global Impression Severity of Illness score. [ Time Frame: 56 days ]

Enrollment: 428
Study Start Date: September 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saredutant 30 mg
Saredutant 30 mg once daily for a maximum of 8 weeks
Drug: Saredutant
oral administration (capsules)
Experimental: Saredutant 100 mg
Saredutant 100 mg once daily for a maximum of 8 weeks
Drug: Saredutant
oral administration (capsules)
Placebo Comparator: Placebo
Placebo for saredutant once daily for one week during the screening phase and for a maximum of 8 weeks during the acute phase
Drug: Placebo
oral administration (capsules)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00390533

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00390533     History of Changes
Other Study ID Numbers: EFC5582
Study First Received: October 19, 2006
Last Updated: April 25, 2016

Keywords provided by Sanofi:
clinical trials

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders processed this record on May 23, 2017