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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00252343

Acronym

LIBRA

Enrollment

360

Registered

2005-11-11

Start date

2005-09-30

Completion date

2007-02-28

Last updated

2009-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorder

Keywords

anxiety disorder

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.

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.

Interventions

DRUGSR58611A

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
14-item Hamilton Anxiety Rating Scale (HAM-A) total score	—

Secondary

Measure	Time frame
Change from baseline in Clinical Global Impression (CGI)	—
Severity of Illness score	—
Safety assessments	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026