Status:
COMPLETED
An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder
Lead Sponsor:
Sanofi
Conditions:
Generalized Anxiety
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 object...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT00390533
Start Date
September 1 2006
End Date
February 1 2008
Last Update
May 24 2016
Active Locations (2)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Macquarie Park, Australia