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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374166
• Other study ID #: DFI5880
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2006
• Last updated: July 25, 2011
• Start date: August 2006
• Est. completion date: February 2008

Study information

• Verified date: July 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Diagnosis of generalized anxiety disorder, as defined by DSM-IV criteria and confirmed by the semi-structured MINI GAD Plus Module.

Exclusion Criteria:

• Total score of less than 22 on the 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Drug:
• SSR149415
Oral administration (capsules)
• Placebo
Oral administration (capsules)
• Paroxetine
Oral administration (capsules)

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score.		8 weeks	No
Secondary	Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.		8 weeks	No