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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Generalized Anxiety

Intervention / Treatment
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* Drug: Saredutant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saredutant 30 mg<br>Saredutant 30 mg once daily for a maximum of 8 weeks | Drug: Saredutant<br>* oral administration (capsules)<br>|
| Experimental: Saredutant 100 mg<br>Saredutant 100 mg once daily for a maximum of 8 weeks | Drug: Saredutant<br>* oral administration (capsules)<br>|
| Placebo Comparator: Placebo<br>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<br>* oral administration (capsules)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score. |  | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Day 56 of treatment in the Clinical Global Impression Severity of Illness score. |  | 56 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, clinical trials