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
Patients diagnosed with Major Depressive Disorder, Recurrent according to DSM-IV-TR criteria Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) and assessed with the Mini International Neuropsychiatric Interview (MINI)
Total score on the Montgomery and Asberg Depression Rating Scale (MADRS) \> 28
At W12 (V7), patients will be randomized into the double-blind treatment phase if they have MADRS total score \< 12
You may not be if
Patients with a significant risk of suicide.
Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
Patients with a current depressive episode secondary to a general medical disorder.
Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder.
Patients with severe or unstable concomitant medical conditions
Patients with clinically significant abnormal laboratory value at screening
The investigator will evaluate whether there are other reasons why a patient may not participate
