- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00332891
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder (ELECTRA)
March 6, 2009 updated by: Sanofi
An 8-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Paroxetine (20 mg q24) as Positive Control, Evaluating the Efficacy and Safety of 2 Fixed Doses of SR58611A (175 mg q12 and 350 mg q12) in Outpatients With GAD
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 350 mg and 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
Study Overview
Study Type
Interventional
Enrollment (Actual)
508
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sofia, Bulgaria
- Sanofi-Aventis Administrative Office
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Zagreb, Croatia
- Sanofi-Aventis Administrative Office
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Praha, Czech Republic
- Sanofi-Aventis Administrative Office
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Warszawa, Poland
- Sanofi-Aventis Administrative Office
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Belgrade, Serbia
- Sanofi-Aventis Administrative Office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients suffering from generalized anxiety disorder (GAD) as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module
- Total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) equal or above 20.
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
June 1, 2006
First Submitted That Met QC Criteria
June 1, 2006
First Posted (Estimate)
June 2, 2006
Study Record Updates
Last Update Posted (Estimate)
March 9, 2009
Last Update Submitted That Met QC Criteria
March 6, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC5891
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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