NCT00397098|TerminatedPhase 3

Study Stopped

reprioritization of indications

Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder

VEGA

A Double-Blind Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A Versus Placebo in the Prevention of Relapse of Anxiety up to 1 Year in Patients With GAD Improved After 12 Weeks of Open Label Treatment With SR58611A.

Sanofi ClinicalTrials.gov

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2 other identifiers

LTE5894EudraCT 2006-002253-71

Study Type

interventional

Target

257

Locations

9 countries

Sites

Timeline

RegisteredNov 2006

StartedNov 2006

CompletionSep 2007

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of SR58611A (350 mg BID) compared to placebo in the prevention of relapse of anxiety, in patients with Generalized Anxiety Disorder improved after 12 weeks of treatment with SR58611A. The primary objective is to evaluate the efficacy of SR58611A 350mg BID compared to placebo over a 24 to 52-week treatment period. The secondary objective is to assess the safety and tolerability of SR58611A in patients with GAD.

Trial Health

Monitor

Trial Health Score

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

Enrollment

257

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Nov 2006

Shorter than P25 for phase_3

Geographic Reach

9 countries

9 active sites

Status

terminated

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

10 months study duration

Study Start

First participant enrolled

November 1, 2006

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed

Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

November 7, 2006

Last Update Submit

March 10, 2009

Conditions

Anxiety Disorders

Keywords

Anxiety disorders, Relapse prevention

Outcome Measures

Primary Outcomes (4)

The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by either:
HAM-A total score ≥ 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out,or
Any drop-out for lack of efficacy (according to investigator's decision),or
Prescription/use of alternative or additional treatments for relief of psychiatric symptoms.

Secondary Outcomes (2)

Change from baseline (V7) in:-Clinical Global Impression (CGI) Severity of Illness Score
Hamilton Anxiety Rating Scale (HAM-A)

Interventions

SR58611ADRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

For entry into the open phase:
Patients suffering from generalized anxiety disorder, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and assessed with the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder (GAD) module.
With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) \> 20 at V1(D-4) and V2 (D-1).
For entry into the double-blind randomized phase:
Improved patients with HAM-A score \< 11 at V7 (W12).

You may not qualify if:

Inpatients.
Patients with a diagnosis of Major Depressive Disorder (DSM IV-TR) within 6 months of screening.
Patients with a MADRS total score \> 18 at screening or baseline.
Patients at immediate risk for suicidal behaviour.
Patients with other current (within 6 months) anxiety disorder according to the MINI
Patients with a lifetime history according to the MINI of: Bipolar disorder, Psychotic disorder, Antisocial personality disorder.
Patients with a current history according to the MINI of: Anorexia nervosa or bulimia nervosa in the past 6 months, Alcohol or substance dependence or abuse in the past 12 months, except nicotine or caffeine dependence.
The investigator will evaluate whether there are other reasons why a patient may not participate.

Contact the study team to confirm eligibility.