An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients

Major Depressive Disorder Clinical Trial

— FIDELIO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822744
• Other study ID #: DFI10560
• Secondary ID: 2008-001718-26
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2009
• Last updated: March 14, 2013
• Start date: December 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• SSR411298
Form: capsule Route: oral administration with food
• Escitalopram
Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules) Route: oral administration with food
• Placebo (for SSR411298)
Form: capsule Route: oral administration with food

Locations

Country	Name	City	State
Chile	Sanofi-Aventis Administrative Office	Santiago
Mexico	Sanofi-Aventis Administrative Office	Mexico
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Slovakia	Sanofi-Aventis Administrative Office	Brastislava
South Africa	Sanofi-Aventis Administrative Office	Midrand
Ukraine	Sanofi-Aventis Administrative Office	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Chile,  Mexico,  Romania,  Russian Federation,  Slovakia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	17-item Hamilton Depression Rating Scale (HAM-D) total score	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.	8 weeks (from D-1 (before randomization) up to D56)	No
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS) total score	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.	8 weeks (from D-1 (before randomization) up to D56)	No
Secondary	Clinical Global Impression (CGI) scores	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.	D-1 (before randomization) and D56	No
Secondary	HAM-D depressed mood item score, factor scores and core item score		8 weeks (from D-1 (before randomization) up to D56)	No
Secondary	Geriatric Depression Scale (GDS) total score	The GDS is a 15-item self report scale used to assess the more specific aspects of depression in elderly depressed patients.	D-1 (before randomization) and D56	No
Secondary	Sheehan Disability Scale (SDS) total score	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.	D-1 (before randomization) and D56	No
Secondary	Hamilton Anxiety Rating scale (HAM-A) total score	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.	D-1 (before randomization) and D56	No
Secondary	Overview of Adverse Events (AE)		up to 9 weeks (from first study drug intake up to 7 days after last study drug intake)	Yes
Secondary	SSR411298 plasma concentration	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.	predose and 3-5 hours after study drug intake on Day 21 and Day 56	No