An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Generalized Anxiety Disorder

Anxiety Disorders Clinical Trial

— GEMINI  

Official title:

An Eight-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fixed Dose of SR58611A 350 mg Twice a Day in Elderly Patients With Generalized Anxiety Disorder With an Optional Twenty-Four Week Extension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00535340
• Other study ID #: EFC5895
• Secondary ID: EudraCT 2006-004
• Status: Terminated
• Phase: Phase 3
• First received: September 25, 2007
• Last updated: March 10, 2009
• Start date: March 2007
• Est. completion date: August 2007

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyRomania: National Medicines AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A).

Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility and quality of life in elderly patients with GAD and to evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with Generalized Anxiety Disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and supported by the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder module

Exclusion Criteria:

• Minimum total score of less than 22 on the 14-item HAM-A scale

• Total score of 18 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)

• Mini-Mental State Examination (MMSE) score of 22 or less

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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:
• SR58611A

Locations

Country	Name	City	State
Austria	Sanofi-Aventis Administrative Office	Vienna
Croatia	Sanofi-Aventis Administrative Office	Zagreb
Finland	Sanofi-Aventis Administrative Office	Helsinki
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Slovakia	Sanofi-Aventis Administrative Office	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Austria,  Croatia,  Finland,  Romania,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to visit 7 (Day 56) in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score
Secondary	Clinical Global Impression (CGI) Severity of Illness Score
Secondary	Adverse events

External Links

•   Link