A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
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
1 other identifier
interventional
440
1 country
19
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Shorter than P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMay 9, 2014
May 1, 2014
October 7, 2005
May 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (19)
Pacific Institute for Medical Research, Inc.
Los Angeles, California, 90024, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Affiliated Research Institute
San Diego, California, 92108, United States
Health Quest Clinical Trials
San Diego, California, 92123, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
UF Behavioral Health Clinic
Jacksonville, Florida, 32257, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Atlanta Institute of Medicine & Research - Atlanta Clinic
Atlanta, Georgia, 30328, United States
Cunningham Clinical Research, LLC
Edwardsville, Illinois, 62025, United States
LSUHSC Anxiety and Mood Disorders Clinic
New Orleans, Louisiana, 70115, United States
Summit Research Network
Farmington Hills, Michigan, 48336, United States
Social Psychiatry Research Inst.
Brooklyn, New York, 11235, United States
Eastside Comprehensive Medical Center
New York, New York, 10021, United States
Medical and Behavioral Health Research, PC
New York, New York, 10023, United States
Hartford Research Group Ltd.
Cincinnati, Ohio, 45242, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301, United States
South East Health Consultants, LLC
Charleston, South Carolina, 29407, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Northbrooke Research
Brown Deer, Wisconsin, 53223, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
October 1, 2004
Study Completion
December 1, 2005
Last Updated
May 9, 2014
Record last verified: 2014-05