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Completed

NCT Number: NCT00822744

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office, Santiago, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSR411298

Drug

Form: capsule

Route: oral administration with food

Escitalopram

Drug

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

Route: oral administration with food

Placebo (for SSR411298)

Drug

Form: capsule

Route: oral administration with food

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: FIDELIO

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2009
Registry last updated
Mar 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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