An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Generalized Anxiety Disorder (GEMINI)
This study has been terminated.
(reprioritization of indications)
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00535340
First received: September 25, 2007
Last updated: March 10, 2009
Last verified: March 2009
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Purpose
The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A).
Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility and quality of life in elderly patients with GAD and to evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorders |
Drug: SR58611A |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | An Eight-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fixed Dose of SR58611A 350 mg Twice a Day in Elderly Patients With Generalized Anxiety Disorder With an Optional Twenty-Four Week Extension |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Change from baseline to visit 7 (Day 56) in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score
Secondary Outcome Measures:
- Clinical Global Impression (CGI) Severity of Illness Score
- Adverse events
| Enrollment: | 55 |
| Study Start Date: | March 2007 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients diagnosed with Generalized Anxiety Disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and supported by the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder module
Exclusion Criteria:
- Minimum total score of less than 22 on the 14-item HAM-A scale
- Total score of 18 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)
- Mini-Mental State Examination (MMSE) score of 22 or less
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535340
Locations
| Austria | |
| Sanofi-Aventis Administrative Office | |
| Vienna, Austria | |
| Croatia | |
| Sanofi-Aventis Administrative Office | |
| Zagreb, Croatia | |
| Finland | |
| Sanofi-Aventis Administrative Office | |
| Helsinki, Finland | |
| Romania | |
| Sanofi-Aventis Administrative Office | |
| Bucuresti, Romania | |
| Slovakia | |
| Sanofi-Aventis Administrative Office | |
| Bratislava, Slovakia | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00535340 History of Changes |
| Other Study ID Numbers: | EFC5895, EudraCT 2006-004147-33 |
| Study First Received: | September 25, 2007 |
| Last Updated: | March 10, 2009 |
| Health Authority: | Finland: Finnish Medicines Agency Romania: National Medicines Agency United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Anxiety Anti-Anxiety Agents |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Anti-Anxiety Agents SR 58611A Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013