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

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Depressive Disorder

Treatments

Drug: saredutant (SR48968)
Drug: escitalopram
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00415142
EFC5574

Details and patient eligibility

About

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.

Enrollment

393 patients

Sex

All

Ages

60 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

393 participants in 3 patient groups, including a placebo group

Saredutant 100 mg
Experimental group
Description:
Saredudant100 mg once daily for a maximum of 32 weeks
Treatment:
Drug: saredutant (SR48968)
Escitalopram 10 mg
Active Comparator group
Description:
Escitalopram 10 mg once daily for a maximum of 32 weeks
Treatment:
Drug: escitalopram
Placebo
Placebo Comparator group
Description:
Placebo once daily for one week during screening phase and a maximum of 8 weeks during the acute phase
Treatment:
Drug: placebo

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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