Major Depressive Disorder
Conditions
Keywords
Mental Disorder, Mood Disorder, Depressive Disorder
Brief summary
The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram. The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score =\> 30
Exclusion criteria
* Patient is at immediate risk for suicidal behavior * Patient with psychotic features, catatonic features, seasonal pattern or postpartum 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 * Pregnant, breastfeeding, or likely to become pregnant during the study * Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram The investigator will evaluate whether there are other reasons why a patient may not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Hamilton Depression Rating scale (HAM-D) total score | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score | 8 weeks |
Countries
Belgium, Estonia, Finland, France, Germany, Greece, India, Malaysia, Morocco, South Korea, Taiwan, Tunisia, Turkey (Türkiye)
Outcome results
None listed