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

NCT00417118 | Completed Phase 3 DMC

• 1 other identifier: EFC5583
• Study Type: interventional
• Target: 365
• Locations: 7 countries
• Sites: 7

Brief 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.

Conditions

Generalized Anxiety

Keywords

Anxiety; clinical trials

Outcome Measures

Primary Outcomes (1)

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

  Baseline, Day 56

Secondary Outcomes (1)

• Change from baseline in the Clinical Global Impression Severity of Illness score.

  Baseline, Day 56

Study Arms (3)

Saredutant 100 mg

EXPERIMENTAL

Saredutant 100 mg once daily in the morning for a maximum of 8 weeks

Drug: Saredutant

Escitalopram 10 mg

ACTIVE COMPARATOR

Escitalopram 10 mg once daily in the morning for a maximum of 8 weeks

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Placebo for one week during the run in period and for a maximum of 8 weeks during the active period

Drug: Placebo

Interventions

Saredutant DRUG

oral administration (capsules)

Saredutant 100 mg

Escitalopram DRUG

oral administration (capsules)

Escitalopram 10 mg

Placebo DRUG

oral administration (capsules)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (7)

Sanofi-Aventis Administrative Office

Brussels, Belgium

Location

Sanofi-Aventis Administrative Office

Laval, Canada

Location

Sanofi-Aventis Administrative Office

Helsinki, Finland

Location

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Milan, Italy

Location

Sanofi-Aventis Administrative Office

Stockholm, Sweden

Location

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

SR 48968; Escitalopram

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2006
• First Posted: December 29, 2006
• Study Start: December 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 24, 2016

Record last verified: 2016-04

Locations

TU (1); FI (1); CA (1); BE (1); FR (1); SE (1); IT (1)