Back to resultsA 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gabitril
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility Criteria
Inclusion Criteria: Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S). Exclusion Criteria: Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months Have been diagnosed with any eating disorder within the past six months Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder Have any history of alcohol or substance abuse within the past 3 months Have any history of seizures, including febrile seizures Have any history of head trauma associated with loss of consciousness within the past 15 years
Sites / Locations
- Pacific Institute for Medical Research, Inc.
- Pharmacology Research Institute
- Affiliated Research Institute
- Health Quest Clinical Trials
- Pacific Clinical Research Medical Group
- UF Behavioral Health Clinic
- Janus Center for Psychiatric Research
- Atlanta Institute of Medicine & Research - Atlanta Clinic
- Cunningham Clinical Research, LLC
- LSUHSC Anxiety and Mood Disorders Clinic
- Summit Research Network
- Social Psychiatry Research Inst.
- Eastside Comprehensive Medical Center
- Medical and Behavioral Health Research, PC
- Hartford Research Group Ltd.
- Oregon Center for Clinical Investigations, Inc.
- South East Health Consultants, LLC
- Northwest Clinical Research Center
- Northbrooke Research
Outcomes
Primary Outcome Measures
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale.
Secondary Outcome Measures
Assessment of proportion of responders and
patients in remission according to HAM-A scores and CGI ratings by
visit, assessment of the safety and tolerability in patients with GAD
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00236054
Brief Title
A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
Official Title
A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Flexible-Dosage Study to Evaluate the Efficacy and Safety of Gabitril (up to 16 mg/Day) in the Treatment of Adults With Generalized Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cephalon
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
440 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gabitril
Primary Outcome Measure Information:
Title
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale.
Secondary Outcome Measure Information:
Title
Assessment of proportion of responders and
Title
patients in remission according to HAM-A scores and CGI ratings by
Title
visit, assessment of the safety and tolerability in patients with GAD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S).
Exclusion Criteria:
Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD
Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months
Have been diagnosed with any eating disorder within the past six months
Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder
Have any history of alcohol or substance abuse within the past 3 months
Have any history of seizures, including febrile seizures
Have any history of head trauma associated with loss of consciousness within the past 15 years
Facility Information:
Facility Name
Pacific Institute for Medical Research, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Health Quest Clinical Trials
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
UF Behavioral Health Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Janus Center for Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Atlanta Institute of Medicine & Research - Atlanta Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Cunningham Clinical Research, LLC
City
Edwardsville
State/Province
Illinois
ZIP/Postal Code
62025
Country
United States
Facility Name
LSUHSC Anxiety and Mood Disorders Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Summit Research Network
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Social Psychiatry Research Inst.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Eastside Comprehensive Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Medical and Behavioral Health Research, PC
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Hartford Research Group Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc.
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
South East Health Consultants, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Northbrooke Research
City
Brown Deer
State/Province
Wisconsin
ZIP/Postal Code
53223
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
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