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Trial record 15 of 1949 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Major Depressive Disorder

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

Tracking Information
First Submitted Date  ICMJE January 13, 2009
First Posted Date  ICMJE January 14, 2009
Last Update Posted Date March 15, 2013
Study Start Date  ICMJE December 2008
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
Change from baseline in 17-item Hamilton Depression Rating Scale (HAM-D) total score [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT00822744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
  • Change from baseline in the Clinical Global Impression scale (CGI-1) severity of illness [ Time Frame: at Visit 8 (Day 56) ]
  • Change from baseline in the Hamilton-Anxiety Rating Scale (HAM-D) depressed mood item score [ Time Frame: at Visit 8 (Day 56) ]
  • CGI improvement [ Time Frame: at Visit 8 (Day 56) ]
  • Change from baseline HAM-A totals score [ Time Frame: at Visit 8 (Day 56) ]
  • Change from baseline HAM-D factor scores [ Time Frame: at Visit 8 (Day 56) ]
  • Change from baseline in Sheehan Disability Scale (SDS) total score [ Time Frame: at Visit 8 (Day 56) ]
  • Change form baseline Geriatric Depression Scale (GDS) total score [ Time Frame: at Visit 8 (Day 56) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Eight-week Study of SSR411298 as Treatment for Major Depressive Disorder in Elderly Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: SSR411298

    Form: capsule

    Route: oral administration with food

  • Drug: Escitalopram

    Form: capsule (commercial escitalopram tablets were encapsulated within opaque capsules)

    Route: oral administration with food

  • Drug: Placebo (for SSR411298)

    Form: capsule

    Route: oral administration with food

Study Arms  ICMJE
  • Experimental: SSR411298 10 mg
    SSR411298 10 mg, one capsule once daily for 8 weeks
    Intervention: Drug: SSR411298
  • Experimental: SSR411298 50 mg
    SSR411298 50 mg, one capsule once daily for 8 weeks
    Intervention: Drug: SSR411298
  • Experimental: SSR411298 200 mg
    SSR411298 200 mg, one capsule once daily for 8 weeks
    Intervention: Drug: SSR411298
  • Active Comparator: Escitalopram 10 mg
    Escitalopram 10 mg, one capsule once daily for 8 weeks
    Intervention: Drug: Escitalopram
  • Placebo Comparator: Placebo
    Placebo (for SSR411298), one capsule once daily for 8 weeks
    Intervention: Drug: Placebo (for SSR411298)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2010)
527
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2009)
500
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Mexico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00822744
Other Study ID Numbers  ICMJE DFI10560
2008-001718-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP