NCT00266747|CompletedPhase 3

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

AQUARIUS

An Eight-Week,Dble-Blind,Placebo-Controlled, Multicenter Study With Paroxetine (20 mg q24) as Positive Control, Evaluating the Efficacy, Safety and Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Outpatients With Generalized Anxiety Disorder

Sanofi ClinicalTrials.gov

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1 other identifier

EFC5893

Study Type

interventional

Target

366

Locations

7 countries

Sites

Timeline

RegisteredDec 2005

StartedDec 2005

CompletionJan 2007

Brief Summary

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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

366

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2005

Shorter than P25 for phase_3

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

December 1, 2005

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2005

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed

Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

1.1 years

First QC Date

December 16, 2005

Last Update Submit

March 10, 2009

Conditions

Anxiety Disorders

Keywords

AnxietyAnti-Anxiety AgentsControlled Clinical Trial

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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.

Interventions

SR58611ADRUG

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Out-patients, 18 to 65 years of age.
Patients suffering from generalized anxiety disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module.
With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) ³ 20.
Having given voluntarily their written informed consent to participate in the study.
Able to comply with the protocol and follow written and verbal instructions.
Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A.
Not "placebo responders" (i.e., improvement £ 20 % on HAM-A total score between V1 and V2)

You may not qualify if:

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

Contact the study team to confirm eligibility.