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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00397098




Registration number
NCT00397098
Ethics application status
Date submitted
7/11/2006
Date registered
8/11/2006
Date last updated
12/03/2009

Titles & IDs
Public title
Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder
Scientific 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.
Secondary ID [1] 0 0
EudraCT 2006-002253-71
Secondary ID [2] 0 0
LTE5894
Universal Trial Number (UTN)
Trial acronym
VEGA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorders 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by either:
Timepoint [1] 0 0
Primary outcome [2] 0 0
HAM-A total score = 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out,or
Timepoint [2] 0 0
Primary outcome [3] 0 0
Any drop-out for lack of efficacy (according to investigator's decision),or
Timepoint [3] 0 0
Primary outcome [4] 0 0
Prescription/use of alternative or additional treatments for relief of psychiatric symptoms.
Timepoint [4] 0 0
Secondary outcome [1] 0 0
Change from baseline (V7) in:-Clinical Global Impression (CGI) Severity of Illness Score
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Hamilton Anxiety Rating Scale (HAM-A)
Timepoint [2] 0 0

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2007
Sample size
Target
Accrual to date
Final
257
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
Santiago
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
Italy
State/province [5] 0 0
Milan
Country [6] 0 0
Mexico
State/province [6] 0 0
Mexico
Country [7] 0 0
Russian Federation
State/province [7] 0 0
Moscow
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00397098