NCT00390650

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for phase_3 anxiety

Timeline
Completed

Started Oct 2006

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 6, 2011

Status Verified

April 1, 2011

Enrollment Period

1.1 years

First QC Date

October 19, 2006

Last Update Submit

April 5, 2011

Conditions

Anxiety

Keywords

Anxietyclinical trials

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.

Secondary Outcomes (1)

  • The key secondary efficacy outcome is change from baseline in the Clinical Global Impression Severity of Illness score.

Interventions

SaredutantDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis

Laval, Canada

Location

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Interventions

SR 48968

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Marie TRAD, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 19, 2006

First Posted

October 20, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

April 6, 2011

Record last verified: 2011-04

Locations

US(1)CA(1)