An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder
Primary Purpose
Generalized Anxiety
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Saredutant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety focused on measuring Anxiety, clinical trials
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Saredutant 30 mg
Saredutant 100 mg
Placebo
Arm Description
Saredutant 30 mg once daily for a maximum of 8 weeks
Saredutant 100 mg once daily for a maximum of 8 weeks
Placebo for saredutant once daily for one week during the screening phase and for a maximum of 8 weeks during the acute phase
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 to Day 56 of treatment in the Clinical Global Impression Severity of Illness score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00390533
Brief Title
An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder
Official Title
An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Efficacy, Safety and Tolerability of Two Fixed Doses (100 and 30 mg Once Daily) of Saredutant in Patients With Generalized Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 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 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.
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
428 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saredutant 30 mg
Arm Type
Experimental
Arm Description
Saredutant 30 mg once daily for a maximum of 8 weeks
Arm Title
Saredutant 100 mg
Arm Type
Experimental
Arm Description
Saredutant 100 mg once daily for a maximum of 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for saredutant once daily for one week during the screening phase and for a maximum of 8 weeks during the acute phase
Intervention Type
Drug
Intervention Name(s)
Saredutant
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
56 days
Secondary Outcome Measure Information:
Title
Change from baseline to Day 56 of treatment in the Clinical Global Impression Severity of Illness score.
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Macquarie Park
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder
We'll reach out to this number within 24 hrs