Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
