An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients (FIDELIO)
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ClinicalTrials.gov Identifier: NCT00822744 |
Recruitment Status :
Completed
First Posted : January 14, 2009
Last Update Posted : March 15, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: SSR411298 Drug: Escitalopram Drug: Placebo (for SSR411298) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 527 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | December 2008 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: SSR411298 10 mg
SSR411298 10 mg, one capsule once daily for 8 weeks
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Drug: SSR411298
Form: capsule Route: oral administration with food |
Experimental: SSR411298 50 mg
SSR411298 50 mg, one capsule once daily for 8 weeks
|
Drug: SSR411298
Form: capsule Route: oral administration with food |
Experimental: SSR411298 200 mg
SSR411298 200 mg, one capsule once daily for 8 weeks
|
Drug: SSR411298
Form: capsule Route: oral administration with food |
Active Comparator: Escitalopram 10 mg
Escitalopram 10 mg, one capsule once daily for 8 weeks
|
Drug: Escitalopram
Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules) Route: oral administration with food |
Placebo Comparator: Placebo
Placebo (for SSR411298), one capsule once daily for 8 weeks
|
Drug: Placebo (for SSR411298)
Form: capsule Route: oral administration with food |
- 17-item Hamilton Depression Rating Scale (HAM-D) total score [ Time Frame: 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.
- Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 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.
- Clinical Global Impression (CGI) scores [ Time Frame: 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 [ Time Frame: 8 weeks (from D-1 (before randomization) up to D56) ]
- Geriatric Depression Scale (GDS) total score [ Time Frame: 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.
- Sheehan Disability Scale (SDS) total score [ Time Frame: 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.
- Hamilton Anxiety Rating scale (HAM-A) total score [ Time Frame: 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) [ Time Frame: up to 9 weeks (from first study drug intake up to 7 days after last study drug intake) ]
- SSR411298 plasma concentration [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822744
Chile | |
Sanofi-Aventis Administrative Office | |
Santiago, Chile | |
Mexico | |
Sanofi-Aventis Administrative Office | |
Mexico, Mexico | |
Romania | |
Sanofi-Aventis Administrative Office | |
Bucuresti, Romania | |
Russian Federation | |
Sanofi-Aventis Administrative Office | |
Moscow, Russian Federation | |
Slovakia | |
Sanofi-Aventis Administrative Office | |
Brastislava, Slovakia | |
South Africa | |
Sanofi-Aventis Administrative Office | |
Midrand, South Africa | |
Ukraine | |
Sanofi-Aventis Administrative Office | |
Kiev, Ukraine |
Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00822744 |
Other Study ID Numbers: |
DFI10560 2008-001718-26 ( EudraCT Number ) |
First Posted: | January 14, 2009 Key Record Dates |
Last Update Posted: | March 15, 2013 |
Last Verified: | March 2013 |
Depression Major Depressive Episode Antidepressant |
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |