Anxiety DisordersPhase 3VEGANCT00397098
Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder
A Phase 3 study testing SR58611A in people with Anxiety Disorders, run by Sanofi at 9 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- SR58611A
- How many people
- 257 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Nov 2006to Sep 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
About this 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.
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.
- Conditions
- Anxiety Disorders
- Being tested
- SR58611A
- Keywords
- Anxiety disorders, Relapse prevention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR58611ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2007
- Study completionSep 2007
Why it stopped: reprioritization of indications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397098
- Sponsor's protocol ID
- LTE5894
- Other IDs
- EudraCT 2006-002253-71
- Acronym
- VEGA
- Status last verified
- Mar 2009
- First submitted
- 7 Nov 2006
- Last updated
- 12 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00397098
- Acronym / sponsor ID
- VEGA / LTE5894
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety disorders, Relapse prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: reprioritization of indications
- Enrolment
- 257 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 8 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
- Improved patients with HAM-A score < 11 at V7 (W12).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR58611A | Drug | – |
Primary outcome
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.
2 secondary outcomes
Change from baseline (V7) in:-Clinical Global Impression (CGI) Severity of Illness Score
Hamilton Anxiety Rating Scale (HAM-A)
Results and safety
The study was stopped early (reason given: reprioritization of indications). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2009.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SR58611A in people with Anxiety Disorders, run by Sanofi at 9 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, Chile, France, Germany, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: reprioritization of indications). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by either:. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2009.