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

Phase 2

Completed

• Conditions: Anxiety Disorders
• Interventions: Drug: SSR149415; Drug: Placebo; Drug: Paroxetine

• Registration Number: NCT00374166
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-08
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-26
• Disposition First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Disposition First Posted: 2016-05-25
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSR149415 - 100 mg	Placebo	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	Placebo	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
SSR149415 - 100 mg	SSR149415	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
Placebo	Placebo	Placebo for a maximum of 9 weeks
SSR149415 - 250 mg	SSR149415	SSR149415 250 mg, twice daily for a maximum of 8 weeks
Paroxetine	Paroxetine	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

Primary Outcome Measures

Name	Time	Method
Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.	8 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.	8 weeks

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇸 Bridgewater, New Jersey, United States