An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder

Sanofi

Status and phase: Completed; Phase 3

Conditions: Generalized Anxiety

Treatments: Drug: Placebo; Drug: Saredutant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00390533

SR48968

EFC5582

Details and patient eligibility

About

The primary objective is to evaluate the efficacy of two fixed doses (100 mg and 30 mg once daily) 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: 428 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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428 participants in 3 patient groups, including a placebo group

Saredutant 30 mg

Experimental group

Description:

Saredutant 30 mg once daily for a maximum of 8 weeks

Treatment:

Drug: Saredutant

Saredutant 100 mg

Experimental group

Description:

Saredutant 100 mg once daily for a maximum of 8 weeks

Treatment:

Drug: Saredutant

Placebo

Placebo Comparator group

Description:

Placebo for saredutant once daily for one week during the screening phase and for a maximum of 8 weeks during the acute phase

Treatment:

Drug: Placebo