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Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder (LIBRA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00252343
First Posted: November 11, 2005
Last Update Posted: March 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose
To evaluate the efficacy of a fixed dose of SR58611A (350mg q12) compared to placebo in patients with GeneralizedAnxiety Disorder (GAD) using escitalopram (10 mg qd) as positive control. To evaluate the tolerability and safety of SR58611A in patients with GAD.

Condition Intervention Phase
Anxiety Disorder Drug: SR58611A Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Eight-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Escitalopram (10mg qd) as Positive Control, Evaluating the Efficacy, Safety, 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:
  • 14-item Hamilton Anxiety Rating Scale (HAM-A) total score

Secondary Outcome Measures:
  • Change from baseline in Clinical Global Impression (CGI)
  • Severity of Illness score
  • Safety assessments

Enrollment: 360
Study Start Date: September 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:
The current study will be conducted to evaluate the efficacy, safety, and tolerability of SR58611A (350 mg q12) compared to placebo in patients with generalized anxiety disorder (GAD), using escitalopram (10 mg qd) as a positive control. This is an 8-week, double-blind, randomized, 3-parallel-group, placebo- and escitalopram-controlled, study.A 1-week, placebo, single-blind period precedes the 8-week randomized treatment period. A Safety Follow up Visit (Segment C) is scheduled 1 week after the acute treatmentperiod (Segment B) or early termination. This trial is designed to compare the efficacy, safety, and tolerability of SR58611A to placebo. In this study, escitalopram, a selective serotonin reuptake inhibitor (SSRI) antidepressant, is used as a positive control and has been chosen as the comparator agentas it is approved for treatment of GAD at a dose of 10 mg once daily.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Main inclusion criteria:

  1. Out-patients, 18 year and older.
  2. Generalized Anxiety Disorder (GAD) according toDSM-IV-TR criteria / MINI.
  3. Minimum total score of 20 on the 14-item HamiltonAnxiety Rating Scale (HAM-A)

Exclusion Criteria:

Main exclusion criteria:

  1. Patients with a diagnosis of Major Depressive Disorder within 6 months of study entry.
  2. Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher
  3. Patients who are assessed to have a moderate to high current risk for suicide according to the MINI, or at imminent risk for a suicide attempt
  4. Patients with other current anxiety disorder (within 6 months) assessed with the MINI:- Agoraphobia, social phobia,- Panic disorder,- Obsessive compulsive disorder,- Post-traumatic stress disorder, acute stress disorder.
  5. Patients with a lifetime history according to the MINI of:- Bipolar disorders,- Psychotic disorders,- Antisocial Personality Disorder.
  6. Patients with a current history according to the MINI of:- Anorexia nervosa or bulimia nervosa in the past 6 months,- Alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
  7. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
  8. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252343


Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00252343     History of Changes
Other Study ID Numbers: EFC5892
First Submitted: November 10, 2005
First Posted: November 11, 2005
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by Sanofi:
anxiety disorder

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