An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00374166
First received: September 7, 2006
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with generalized anxiety disorder


Condition Intervention Phase
Anxiety Disorders
Drug: SSR149415
Drug: Placebo
Drug: Paroxetine
Phase 2

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, Multicenter, Double-blind, Placebo- and Paroxetine-controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline to Day 56 in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to Day 56 in the Clinical Global Impression (CGI) Severity of Illness score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 325
Study Start Date: August 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SSR149415 - 250 mg Drug: SSR149415
Oral administration (capsules)
Experimental: SSR149415 - 100 mg Drug: SSR149415
Oral administration (capsules)
Active Comparator: Paroxatine 20 mg Drug: Placebo
Oral administration (capsules)
Drug: Paroxetine
Oral administration (capsules)
Placebo Comparator: Placebo Drug: Placebo
Oral administration (capsules)

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of generalized anxiety disorder, as defined by DSM-IV criteria and confirmed by the semi-structured MINI GAD Plus Module.

Exclusion Criteria:

  • Total score of less than 22 on the HAM-A.
  • Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 17.
  • 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 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
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: NCT00374166

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00374166     History of Changes
Other Study ID Numbers: DFI5880
Study First Received: September 7, 2006
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Anti-anxiety agents
antidepressive agents
controlled clinical trial

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Antidepressive Agents
Paroxetine
Anti-Anxiety Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on July 22, 2014