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

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

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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