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Trial record 77 of 574 for:    ESCITALOPRAM AND Disorders

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415142
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : May 24, 2016
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Drug: saredutant (SR48968) Drug: placebo Drug: escitalopram Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 393 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Saredutant 100 mg
Saredudant100 mg once daily for a maximum of 32 weeks
Drug: saredutant (SR48968)
oral administration (capsules)

Active Comparator: Escitalopram 10 mg
Escitalopram 10 mg once daily for a maximum of 32 weeks
Drug: escitalopram
oral administration (capsules)

Placebo Comparator: Placebo
Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase
Drug: placebo
oral administration (capsules)

Primary Outcome Measures :
  1. Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score. [ Time Frame: Day 56 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00415142

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Mexico, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi Identifier: NCT00415142    
Other Study ID Numbers: EFC5574
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: April 2016
Keywords provided by Sanofi:
Major depressive disorders
Controlled clinical trial
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Pathologic Processes
Behavioral Symptoms
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