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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
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SSR411298 Drug: Escitalopram Drug: Placebo (for SSR411298) Phase 2

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.
Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SSR411298 10 mg
SSR411298 10 mg, one capsule once daily for 8 weeks
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. HAM-D depressed mood item score, factor scores and core item score [ Time Frame: 8 weeks (from D-1 (before randomization) up to D56) ]
  4. 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.

  5. 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.

  6. 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.

  7. 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) ]
  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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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
Keywords provided by Sanofi:
Depression
Major Depressive Episode
Antidepressant
Additional relevant MeSH terms:
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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