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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SSR411298
Escitalopram
Placebo (for SSR411298)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Major Depressive Episode, Antidepressant

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

SSR411298 10 mg

SSR411298 50 mg

SSR411298 200 mg

Escitalopram 10 mg

Placebo

Arm Description

SSR411298 10 mg, one capsule once daily for 8 weeks

SSR411298 50 mg, one capsule once daily for 8 weeks

SSR411298 200 mg, one capsule once daily for 8 weeks

Escitalopram 10 mg, one capsule once daily for 8 weeks

Placebo (for SSR411298), one capsule once daily for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
HAM-D depressed mood item score, factor scores and core item score
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.
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.
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.
Overview of Adverse Events (AE)
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.

Full Information

First Posted
January 13, 2009
Last Updated
March 14, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00822744
Brief Title
An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Major Depressive Episode, Antidepressant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
527 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SSR411298 10 mg
Arm Type
Experimental
Arm Description
SSR411298 10 mg, one capsule once daily for 8 weeks
Arm Title
SSR411298 50 mg
Arm Type
Experimental
Arm Description
SSR411298 50 mg, one capsule once daily for 8 weeks
Arm Title
SSR411298 200 mg
Arm Type
Experimental
Arm Description
SSR411298 200 mg, one capsule once daily for 8 weeks
Arm Title
Escitalopram 10 mg
Arm Type
Active Comparator
Arm Description
Escitalopram 10 mg, one capsule once daily for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for SSR411298), one capsule once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
SSR411298
Intervention Description
Form: capsule Route: oral administration with food
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules) Route: oral administration with food
Intervention Type
Drug
Intervention Name(s)
Placebo (for SSR411298)
Intervention Description
Form: capsule Route: oral administration with food
Primary Outcome Measure Information:
Title
17-item Hamilton Depression Rating Scale (HAM-D) total score
Description
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.
Time Frame
8 weeks (from D-1 (before randomization) up to D56)
Secondary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS) total score
Description
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.
Time Frame
8 weeks (from D-1 (before randomization) up to D56)
Title
Clinical Global Impression (CGI) scores
Description
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.
Time Frame
D-1 (before randomization) and D56
Title
HAM-D depressed mood item score, factor scores and core item score
Time Frame
8 weeks (from D-1 (before randomization) up to D56)
Title
Geriatric Depression Scale (GDS) total score
Description
The GDS is a 15-item self report scale used to assess the more specific aspects of depression in elderly depressed patients.
Time Frame
D-1 (before randomization) and D56
Title
Sheehan Disability Scale (SDS) total score
Description
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.
Time Frame
D-1 (before randomization) and D56
Title
Hamilton Anxiety Rating scale (HAM-A) total score
Description
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.
Time Frame
D-1 (before randomization) and D56
Title
Overview of Adverse Events (AE)
Time Frame
up to 9 weeks (from first study drug intake up to 7 days after last study drug intake)
Title
SSR411298 plasma concentration
Description
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.
Time Frame
predose and 3-5 hours after study drug intake on Day 21 and Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Santiago
Country
Chile
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Bucuresti
Country
Romania
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Brastislava
Country
Slovakia
Facility Name
Sanofi-Aventis Administrative Office
City
Midrand
Country
South Africa
Facility Name
Sanofi-Aventis Administrative Office
City
Kiev
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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