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

Completed · Phase 3

Conditions studied: Anxiety

In brief

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.

Key facts

Study ID

NCT00390650

Run by

Sanofi

People needed

366

Starts

2006-10-01

Expected to finish

2007-11-01

Last updated by the study team

2011-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States
• Sanofi-Aventis — Laval, Canada

Full record on ClinicalTrials.gov

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