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Completed

NCT Number: NCT00415142

An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder

The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.

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Key information

Conditions

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

Age range

60 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Zagreb, Croatia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).

Exclusion criteria

  • Total score of less than 23 on the MADRS.
  • HAM-D total score less than 17.
  • Duration of the current depressive episode less than 1 month or greater than 2 years.
  • Patients with an Mini Mental State Examination score of less than 23.
  • Patients with a history or presence of bipolar disorders or psychotic disorders.
  • Patients with alcohol/substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
  • Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, monoamine oxidase inhibitors within 4 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week.

The investigator will evaluate whether there are other reasons why a patient may not participate

Treatment and study plan

saredutant (SR48968)

Drug

oral administration (capsules)

Placebo

Drug

oral administration (capsules)

Escitalopram

Drug

oral administration (capsules)

Primary outcomes

  1. Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.

    Time frame: Day 56

Secondary outcomes

  1. Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score.

    Time frame: Day 56

  2. Change from baseline to Day 56 in the HAM-D depressed mood item score

    Time frame: Day 56

  3. Change from baseline to Day 56 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score

    Time frame: Day 56

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

An Eight-week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients With Major Depressive Disorder

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 22, 2006
Registry last updated
May 24, 2016

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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