Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder
LIBRA
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
1 other identifier
interventional
360
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedMarch 12, 2009
March 1, 2009
1.4 years
November 10, 2005
March 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
14-item Hamilton Anxiety Rating Scale (HAM-A) total score
Secondary Outcomes (3)
Change from baseline in Clinical Global Impression (CGI)
Severity of Illness score
Safety assessments
Interventions
Eligibility Criteria
You may qualify if:
- Out-patients, 18 year and older.
- Generalized Anxiety Disorder (GAD) according toDSM-IV-TR criteria / MINI.
- Minimum total score of 20 on the 14-item HamiltonAnxiety Rating Scale (HAM-A)
You may not qualify if:
- Patients with a diagnosis of Major Depressive Disorder within 6 months of study entry.
- Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher
- 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
- 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.
- Patients with a lifetime history according to the MINI of:- Bipolar disorders,- Psychotic disorders,- Antisocial Personality Disorder.
- 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.
- Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
- Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 10, 2005
First Posted
November 11, 2005
Study Start
September 1, 2005
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
March 12, 2009
Record last verified: 2009-03