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

Phase 3

Completed

• Conditions: Generalized Anxiety
• Interventions: Drug: Saredutant; Drug: Placebo

• Registration Number: NCT00390533
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-19
• Study First Submitted QC: 2006-10-19
• Study First Posted: 2006-10-20
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-25
• Disposition First Submitted QC: 2016-04-25
• Last Update Submitted: 2016-04-25
• Disposition First Posted: 2016-05-24
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saredutant 100 mg	Saredutant	Saredutant 100 mg once daily for a maximum of 8 weeks
Saredutant 30 mg	Saredutant	Saredutant 30 mg once daily for a maximum of 8 weeks
Placebo	Placebo	Placebo for saredutant once daily for one week during the screening phase and for a maximum of 8 weeks during the acute phase

Primary Outcome Measures

Name	Time	Method
Change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.	56 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline to Day 56 of treatment in the Clinical Global Impression Severity of Illness score.	56 days

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇦🇺 Macquarie Park, Australia