An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder
Completed · Phase 3 · Has a placebo group
Conditions studied: Generalized Anxiety
In brief
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.
Key facts
- Study ID
- NCT00390533
- Run by
- Sanofi
- People needed
- 428
- Starts
- 2006-09-01
- Expected to finish
- 2008-02-01
- Last updated by the study team
- 2016-05-24
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 Administrative Office — Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office — Macquarie Park, Australia
Full record on ClinicalTrials.gov
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