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

Primary Purpose

Generalized Anxiety

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Saredutant

Escitalopram

Placebo

About this trial

This is an interventional treatment trial for Generalized Anxiety focused on measuring Anxiety, clinical trials

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Saredutant 100 mg

Escitalopram 10 mg

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00417118

First Posted

December 28, 2006

Last Updated

April 25, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00417118

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxiety

Keywords

Anxiety, clinical trials

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

365 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Saredutant 100 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Escitalopram 10 mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Saredutant

Intervention Description

oral administration (capsules)

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Intervention Description

oral administration (capsules)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral administration (capsules)

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline, Day 56

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline, Day 56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name