Clinical trial NCT00397098: Prevention of Relapse Study of SR58611A in Improved Patients With Generalized Anxiety Disorder
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anxiety Disorders
Keywords: Anxiety disorders, Relapse prevention
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-08
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary criterion is the time to relapse of anxious symptoms (in days) from randomization date defined by either:
measure: HAM-A total score ≥ 15 confirmed at a subsequent visit 2 weeks later unless the patient drops out,or
measure: Any drop-out for lack of efficacy (according to investigator's decision),or
measure: Prescription/use of alternative or additional treatments for relief of psychiatric symptoms.
Secondary outcomes:
measure: Change from baseline (V7) in:-Clinical Global Impression (CGI) Severity of Illness Score
measure: Hamilton Anxiety Rating Scale (HAM-A)
Other outcomes:
Locations:
city: Macquarie Park
country: Australia
facility: Sanofi-Aventis Administrative Office
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-Aventis Administrative Office
city: Milan
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: