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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00332891
First received: June 1, 2006
Last updated: March 6, 2009
Last verified: March 2009
  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 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


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 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

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: 508
Study Start Date: March 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332891

Locations
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Serbia
Sanofi-Aventis Administrative Office
Belgrade, Serbia
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: NCT00332891     History of Changes
Other Study ID Numbers: EFC5891
Study First Received: June 1, 2006
Last Updated: March 6, 2009
Health Authority: Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Poland: Ministry of Health
Czech Republic: State Institute for Drug Control

Keywords provided by Sanofi:
Anxiety
Anti-Anxiety Agents
controlled Clinical Trials

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes
Amibegron
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014