A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
This study has been completed.
Sponsor:
Cephalon
Information provided by:
Cephalon
ClinicalTrials.gov Identifier:
NCT00236054
First received: October 7, 2005
Last updated: April 12, 2006
Last verified: April 2006
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Generalized Anxiety Disorder |
Drug: Gabitril |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cephalon:
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
| Estimated Enrollment: | 440 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | December 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236054
Locations
| United States, California | |
| Pacific Institute for Medical Research, Inc. | |
| Los Angeles, California, United States, 90024 | |
| Pharmacology Research Institute | |
| Newport Beach, California, United States, 92660 | |
| Affiliated Research Institute | |
| San Diego, California, United States, 92108 | |
| Health Quest Clinical Trials | |
| San Diego, California, United States, 92123 | |
| Pacific Clinical Research Medical Group | |
| Upland, California, United States, 91786 | |
| United States, Florida | |
| UF Behavioral Health Clinic | |
| Jacksonville, Florida, United States, 32257 | |
| Janus Center for Psychiatric Research | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Atlanta Institute of Medicine & Research - Atlanta Clinic | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Illinois | |
| Cunningham Clinical Research, LLC | |
| Edwardsville, Illinois, United States, 62025 | |
| United States, Louisiana | |
| LSUHSC Anxiety and Mood Disorders Clinic | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Michigan | |
| Summit Research Network | |
| Farmington Hills, Michigan, United States, 48336 | |
| United States, New York | |
| Social Psychiatry Research Inst. | |
| Brooklyn, New York, United States, 11235 | |
| Medical and Behavioral Health Research, PC | |
| New York, New York, United States, 10023 | |
| Eastside Comprehensive Medical Center | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Hartford Research Group Ltd. | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Oregon | |
| Oregon Center for Clinical Investigations, Inc. | |
| Salem, Oregon, United States, 97301 | |
| United States, South Carolina | |
| South East Health Consultants, LLC | |
| Charleston, South Carolina, United States, 29407 | |
| United States, Washington | |
| Northwest Clinical Research Center | |
| Bellevue, Washington, United States, 98004 | |
| United States, Wisconsin | |
| Northbrooke Research | |
| Brown Deer, Wisconsin, United States, 53223 | |
Sponsors and Collaborators
Cephalon
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00236054 History of Changes |
| Other Study ID Numbers: | C6671/3032/AX/US |
| Study First Received: | October 7, 2005 |
| Last Updated: | April 12, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Tiagabine Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs GABA Agonists GABA Agents |
ClinicalTrials.gov processed this record on June 18, 2013