A North-American Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00390650
First received: October 19, 2006
Last updated: April 5, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety |
Drug: Saredutant |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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 Outcome Measures:
- The key secondary efficacy outcome is change from baseline in the Clinical Global Impression Severity of Illness score.
| Enrollment: | 366 |
| Study Start Date: | October 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00390650 History of Changes |
| Other Study ID Numbers: | EFC5581, SR48968 |
| Study First Received: | October 19, 2006 |
| Last Updated: | April 5, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by Sanofi:
|
Anxiety clinical trials |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013