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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00266747
• Date of registration: 16/12/2005
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder AQUARIUS
• Scientific title: An Eight-Week,Dble-Blind,Placebo-Controlled, Multicenter Study With Paroxetine (20 mg q24) as Positive Control, Evaluating the Efficacy, Safety and Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With Generalized Anxiety Disorder
• Date of first enrolment: December 2005
• Target sample size: 366
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00266747
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Estonia, France, Mexico, Russian Federation, South Africa, Sweden, United States

Contacts

• Name: ICD CSD
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion Criteria:

- Out-patients, 18 to 65 years of age.

- Patients suffering from generalized anxiety disorder (GAD) as defined by Diagnostic
and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)
criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI)
plus GAD Module.

- With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) ³ 20.

- Having given voluntarily their written informed consent to participate in the study.

- Able to comply with the protocol and follow written and verbal instructions.

- For inclusion into Segment B of the study, patients must fulfill the following
criteria:

- All Segment A inclusion criteria.

- Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A.

- Not "placebo responders" (i.e., improvement £ 20 % on HAM-A total score between V1
and V2)

Exclusion Criteria:

- Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within
6 months of study entry.

- Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18
or higher at screening or baseline visits.

- Patients having a moderate to high current risk for suicide.

- Patients with other current anxiety disorder assessed with the MINI: agoraphobia,
social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress
disorder, acute stress disorder.

- Patients with a lifetime history according to the MINI of: bipolar disorders,
psychotic disorders, antisocial personality disorder.

- Patients with severe or unstable concomitant medical conditions according to the
Investigator's judgment.

- Females who are pregnant or lactating.

- Female patients of childbearing potential must use an effective method of birth
control during the entire study period.

- Patients with positive test for any illicit drug included in the urine drug screen.

- Participation in a clinical trial of an experimental therapy within 3 months prior to
screening



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Anxiety Disorders

Intervention(s)

Drug: SR58611A

Primary Outcome(s)

The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.

Secondary Outcome(s)

The main secondary outcomes are the changes from baseline to Day 56 of treatment in the CGI Severity of Illness Score, percentage of patients with HAM-A treatment response and change from baseline in the HAM-A somatic and psychic anxiety factor scores.

Secondary ID(s)

EFC5893

Source(s) of Monetary Support

Please refer to primary and secondary sponsors