Back to resultsA 10-Week Study for Efficacy and Safety Study 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 3 months of screening 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
- Birmingham Research Group
- Southwestern Research Institute
- Pharmacology Research Institute
- Pacific Clinical Research
- Carman Research
- Hawaii Clinical Research Center
- Hartford Research Group
- Summit Research Network
- CNS Research Institute
- Social Psychiatry Research Inst.
- Neurobehavioral Research, Inc.
- Social Psychiatry Research Inst.
- The Medical Research Network
- Northcoast Clinical Trials
- University of Oklahoma Health Sciences Center
- Summit Research Network
- University of Pennsylvania
- Carolina Clinical Research Services
- Radiant Research, Salt Lake City
- Comprehensive Neuroscience of Northern Virginia
- Summit Research Network
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
NCT00236067
Brief Title
A 10-Week Study for Efficacy and Safety Study 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
March 2006 (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 patients in remission according to HAM-A scores and CGI ratings by 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 3 months of screening
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
Birmingham Research Group
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Southwestern Research Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Pharmacology Research Institute
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Pacific Clinical Research
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Hawaii Clinical Research Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Hartford Research Group
City
Florence
State/Province
Kentucky
ZIP/Postal Code
41042
Country
United States
Facility Name
Summit Research Network
City
Okemos
State/Province
Michigan
ZIP/Postal Code
48864
Country
United States
Facility Name
CNS Research Institute
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Social Psychiatry Research Inst.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Lawrence
State/Province
New York
ZIP/Postal Code
11559
Country
United States
Facility Name
Social Psychiatry Research Inst.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The Medical Research Network
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Facility Name
Northcoast Clinical Trials
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Carolina Clinical Research Services
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Radiant Research, Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107-7591
Country
United States
Facility Name
Comprehensive Neuroscience of Northern Virginia
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22201
Country
United States
Facility Name
Summit Research Network
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
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A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
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