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

Generalized Anxiety Clinical Trial

Official title:

An Eight-Week, 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 Patients With Generalized Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417118
• Other study ID #: EFC5583
• Status: Completed
• Phase: Phase 3
• First received: December 28, 2006
• Last updated: July 28, 2011
• Start date: December 2006
• Est. completion date: April 2008

Study information

• Verified date: July 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaFinland: Finnish Medicines AgencyTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety

Intervention

Drug:
• Saredutant
oral administration (capsules)
• Escitalopram
oral administration (capsules)
• Placebo
oral administration (capsules)

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Administrative Office	Brussels
Canada	Sanofi-Aventis Administrative Office	Laval
Finland	Sanofi-Aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Italy	Sanofi-Aventis Administrative Office	Milano
Sweden	Sanofi-Aventis Administrative Office	Stockholm
Turkey	Sanofi-Aventis Administrative Office	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  Canada,  Finland,  France,  Italy,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.		56 days	No
Secondary	Change from baseline in the Clinical Global Impression Severity of Illness score.		56 days	No