Clinical trial NCT00822744: An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients
Official title: An Eight-week, Multicenter, Randomized, Double-blind, Placebo-controlled Dose-finding Study, With Escitalopram (10 mg Daily) as Active Control, to Evaluate the Efficacy, Safety and Tolerability of Three Fixed Doses of SSR411298 (10, 50, or 200 mg Daily) in Elderly Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Depression
Major Depressive Episode
Antidepressant
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 527
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 17-item Hamilton Depression Rating Scale (HAM-D) total score
timeFrame: 8 weeks (from D-1 (before randomization) up to D56)
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) total score
timeFrame: 8 weeks (from D-1 (before randomization) up to D56)
measure: Clinical Global Impression (CGI) scores
timeFrame: D-1 (before randomization) and D56
measure: HAM-D depressed mood item score, factor scores and core item score
timeFrame: 8 weeks (from D-1 (before randomization) up to D56)
measure: Geriatric Depression Scale (GDS) total score
timeFrame: D-1 (before randomization) and D56
measure: Sheehan Disability Scale (SDS) total score
timeFrame: D-1 (before randomization) and D56
measure: Hamilton Anxiety Rating scale (HAM-A) total score
timeFrame: D-1 (before randomization) and D56
measure: Overview of Adverse Events (AE)
timeFrame: up to 9 weeks (from first study drug intake up to 7 days after last study drug intake)
measure: SSR411298 plasma concentration
timeFrame: predose and 3-5 hours after study drug intake on Day 21 and Day 56
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Brastislava
country: Slovakia
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Kiev
country: Ukraine
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: