Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00397098

Purpose

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.

Condition	Intervention	Phase
Anxiety Disorders	Drug: SR58611A	Phase III

MedlinePlus related topics: Anxiety

Drug Information available for: SR 58611A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 Outcome Measures:

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

Enrollment:	257
Study Start Date:	November 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397098

Locations

Australia
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	LTE5894, EudraCT 2006-002253-71
Study First Received:	November 7, 2006
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00397098
Health Authority:	South Africa: Medicines Control Council; Chile: Instituto de Salud Publica de Chile; France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

Anxiety disorders, Relapse prevention

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
SR 58611A

Additional relevant MeSH terms:

Neurotransmitter Agents
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

Adrenergic beta-Agonists
Physiological Effects of Drugs
Pharmacologic Actions
Adrenergic Agonists

ClinicalTrials.gov processed this record on January 14, 2009