Major Depressive Disorder
Conditions
Keywords
Depression, Major Depressive Episode, Antidepressant
Brief summary
The primary objective of this study is to evaluate the efficacy of 3 fixed doses of SSR411298 (10, 50 or 200 mg daily) compared to placebo, in elderly patients with Major Depressive Disorder (MDD), based on the 17-item Hamilton Depression Rating Scale. Secondary objectives are: * To evaluate the tolerability and safety of an 8-week treatment with SSR411298 versus placebo in elderly patients with MDD. * To evaluate the effect of SSR411298 on disability, anxiety, cognitive function, sleep, pain and somatic symptoms related to depression, and bone markers. * To assess SSR411298 plasma concentrations. * To assess plasma endocannabinoid concentrations.
Detailed description
The study period for a participants is approximately 10 weeks including a screening up to 1 week, 8-week treatment and 1-week follow-up.
Interventions
DRUGSSR411298
Form: capsule Route: oral administration with food
DRUGEscitalopram
Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules) Route: oral administration with food
Form: capsule Route: oral administration with food
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elderly patient with recurrent Major Depressive Disorder
Exclusion criteria
* Duration of current depressive episode greater than 2 years; * Mild depression as measured by standard clinical research scales; * Cognitive disturbance; * Significant suicide risk; * Other psychiatric conditions that would obscure the results of the study; * History of failure to respond to antidepressant treatment. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 17-item Hamilton Depression Rating Scale (HAM-D) total score | 8 weeks (from D-1 (before randomization) up to D56) | The HAM-D consists of 17 items assessing signs and symptoms of depression. All items are scored with a severity rating from 0 (not present) to 2 or 4 (very severe), depending on the item. The minimum and maximum possible scores are 0 and 52, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression (CGI) scores | D-1 (before randomization) and D56 | The CGI-1 Severity of Illness score is rated on a 1 to 7 point scale. The CGI-2 Improvement score is a component of the CGI; the Improvement score captures the investigator's clinical impression regarding global improvement (or worsening) on a 7-point scale. |
| HAM-D depressed mood item score, factor scores and core item score | 8 weeks (from D-1 (before randomization) up to D56) | — |
| Geriatric Depression Scale (GDS) total score | D-1 (before randomization) and D56 | The GDS is a 15-item self report scale used to assess the more specific aspects of depression in elderly depressed patients. |
| Montgomery-Asberg Depression Rating Scale (MADRS) total score | 8 weeks (from D-1 (before randomization) up to D56) | The MADRS consists of 10 items assessing signs and symptoms of depression. All items are scored with a severity rating from 0 (not present) to 6 (most severe). The minimum and maximum possible scores are 0 and 60, respectively. |
| Hamilton Anxiety Rating scale (HAM-A) total score | D-1 (before randomization) and D56 | The HAM-A consists of 14 items assessing signs and symptoms of anxiety. All items are scored with a severity rating from 0 (not present) to 2 or 4 (very severe), depending on the item. The minimum and maximum possible scores are 0 and 56 respectively. |
| Overview of Adverse Events (AE) | up to 9 weeks (from first study drug intake up to 7 days after last study drug intake) | — |
| SSR411298 plasma concentration | predose and 3-5 hours after study drug intake on Day 21 and Day 56 | Plasma concentrations of SSR411298 are determined by a validated liquid chromatography tandem mass spectrometry method with a lower limit of quantification of 10 ng/mL. |
| Sheehan Disability Scale (SDS) total score | D-1 (before randomization) and D56 | The SDS contains 3 questions, which assesses interference in three domains, work and school, family life and home responsibilities, and social life. Each question is answered on a 10-point Likert Scale. |
Countries
Chile, Mexico, Romania, Russia, Slovakia, South Africa, Ukraine
Outcome results
None listed