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An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Generalized Anxiety

Treatments

Drug: Escitalopram
Drug: Saredutant
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00417118
EFC5583

Details and patient eligibility

About

The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.

Enrollment

365 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of generalized anxiety disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) Plus Generalized Anxiety Disorder module.

Exclusion criteria

  • Total score of less than 22 on the HAM-A.
  • Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 18.
  • Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.
  • Patients with alcohol dependence or abuse or 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, antidepressants including Monoamine Oxidase Inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.

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

365 participants in 3 patient groups, including a placebo group

Saredutant 100 mg
Experimental group
Description:
Saredutant 100 mg once daily in the morning for a maximum of 8 weeks
Treatment:
Drug: Saredutant
Escitalopram 10 mg
Active Comparator group
Description:
Escitalopram 10 mg once daily in the morning for a maximum of 8 weeks
Treatment:
Drug: Escitalopram
Placebo
Placebo Comparator group
Description:
Placebo for one week during the run in period and for a maximum of 8 weeks during the active period
Treatment:
Drug: Placebo

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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