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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:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00535340
First received: September 25, 2007
Last updated: March 10, 2009
Last verified: March 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Disease
Mental Disorders
Pathologic Processes
Amibegron
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014