An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder (AQUARIUS)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00266747
First received: December 16, 2005
Last updated: March 10, 2009
Last verified: March 2009
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Purpose
The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of life in patients with GAD and to evaluate safety of SR58611A.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorders |
Drug: SR58611A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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 Measures:
- 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.
| Enrollment: | 366 |
| Study Start Date: | December 2005 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266747
Locations
| Argentina | |
| Sanofi-Aventis Administrative Office | |
| Buenos Aires, Argentina | |
| Austria | |
| Sanofi-Aventis Administrative Office | |
| Vienna, Austria | |
| Estonia | |
| Sanofi-Aventis Administrative Office | |
| Tallinn, Estonia | |
| France | |
| Sanofi-Aventis Administrative Office | |
| Paris, France | |
| Russian Federation | |
| Sanofi-Aventis Administrative Office | |
| Moscow, Russian Federation | |
| South Africa | |
| Sanofi-Aventis Administrative Office | |
| Midrand, South Africa | |
| Sweden | |
| Sanofi-Aventis Administrative Office | |
| Bromma, Sweden | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00266747 History of Changes |
| Other Study ID Numbers: | EFC5893 |
| Study First Received: | December 16, 2005 |
| Last Updated: | March 10, 2009 |
| Health Authority: | South Africa: Medicines Control Council France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Sweden: Medical Products Agency |
Keywords provided by Sanofi:
|
Anxiety Anti-Anxiety Agents Controlled Clinical Trial |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Anti-Anxiety Agents SR 58611A Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013