An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder
NCT ID: NCT00390533
Last Updated: 2016-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
428 participants
INTERVENTIONAL
2006-09-30
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Saredutant 30 mg
Saredutant 30 mg once daily for a maximum of 8 weeks
Saredutant
oral administration (capsules)
Saredutant 100 mg
Saredutant 100 mg once daily for a maximum of 8 weeks
Saredutant
oral administration (capsules)
Placebo
Placebo for saredutant once daily for one week during the screening phase and for a maximum of 8 weeks during the acute phase
Placebo
oral administration (capsules)
Interventions
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Saredutant
oral administration (capsules)
Placebo
oral administration (capsules)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Macquarie Park, , Australia
Countries
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Other Identifiers
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SR48968
Identifier Type: -
Identifier Source: secondary_id
EFC5582
Identifier Type: -
Identifier Source: org_study_id
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