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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSR149415 - 250 mg | Experimental | SSR149415 250 mg, twice daily for a maximum of 8 weeks |
|
| SSR149415 - 100 mg | Experimental | 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 |
|
| Paroxetine | Active Comparator | 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 |
|
| Placebo | Placebo Comparator | Placebo for a maximum of 9 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSR149415 | Drug | Oral administration (capsules of 50 and 100 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
The investigator will evaluate whether there are other reasons why a patient may not participate.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23146246 | Derived | Griebel G, Beeske S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012 Nov;73(11):1403-11. doi: 10.4088/JCP.12m07804. Epub 2012 Oct 16. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C456029 | 1-(5-chloro-1-((2,4-dimethoxyphenyl)sulfonyl)-3-(2-methoxyphenyl)-2-oxo-2,3-dihydro-1H-indol-3-yl)-4-hydroxy-N,N-dimethyl-2-pyrrolidinecarboxamide |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Oral administration (capsules) |
|
| Paroxetine | Drug | Oral administration (capsules) |
|