An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder

Study Overview
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Brief Summary
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The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with generalized anxiety disorder

Official Title
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An Eight-week, Multicenter, Double-blind, Placebo- and Paroxetine-controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Generalized Anxiety Disorder

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Drug: SSR149415
* Drug: Placebo
* Drug: Paroxetine


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, 4th Edition (DSM-IV) criteria and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI) General Anxiety Disorder (GAD) Plus Module. Exclusion Criteria: Total score of less than 22 on the (Hamilton Anxiety rating scale)HAM-A. Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 17. 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
Maximum Age: 64 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: SSR149415 - 250 mg<br>SSR149415 250 mg, twice daily for a maximum of 8 weeks | Drug: SSR149415<br>* Oral administration (capsules of 50 and 100 mg)<br>|
| Experimental: SSR149415 - 100 mg<br>SSR149415 100 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks | Drug: SSR149415<br>* Oral administration (capsules of 50 and 100 mg)<br>Drug: Placebo<br>* Oral administration (capsules)<br>|
| Active Comparator: Paroxetine<br>Paroxetine 20 mg and additional placebo capsules in order that all patients are being administered three capsules twice daily for a maximum of 8 weeks | Drug: Placebo<br>* Oral administration (capsules)<br>Drug: Paroxetine<br>* Oral administration (capsules)<br>|
| Placebo Comparator: Placebo<br>Placebo for a maximum of 9 weeks | 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 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-anxiety agents, antidepressive agents, controlled clinical trial