Anxiety DisorderPhase 3NCT00236015
A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
A Phase 3 study testing Gabitril in people with Anxiety Disorder, run by Cephalon at 54 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- Gabitril
- How many people
- 880 participants
- Where
- 54 sitesin 2 countries
- Study dates
- Nov 2004to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
54 sites in 2 countries.
54 sites in 2 countries
United States48 sites
Emory University
Atlanta, Georgia, 30329
American Medical Research
Aurora, Illinois, 60506
Future Search Trials
Austin, Texas, 78756
Claghorn-Lesem Research Clinic, Inc.
Bellaire, Texas, 77401
Mood Disorders Research Clinic; UT Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Midwest Clinical Research Center
Dayton, Ohio, 45408
Radiant Research
Denver, Colorado, 80212
Wayne State University
Detroit, Michigan, 48207
Valley Clinical Research
El Centro, California, 92243
Oregon Center for Clinical Investigations, Inc.
Eugene, Oregon, 97401
University of Connecticut Health Center
Farmington, Connecticut, 06030-6415
Indiana University Hospital AOC
Indianapolis, Indiana, 46202
Radiant Research Irvine
Irvine, California, 92618
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Radiant Research
Las Vegas, Nevada, 89146
Pharmacology Research Institute
Los Alamitos, California, 90720
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Pivotol Research Centers
Mesa, Arizona, 85210
Miami Research Associates
Miami, Florida, 33173
Dean Foundation
Middleton, Wisconsin, 53562
Center for Emotional Fitness
Moorestown, New Jersey, 08057
Medark Clinical Trials and Research
Morganton, North Carolina, 28655
Fieve Clinical Services, Inc.
New York, New York, 10021
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19401
Henry Lahmeyer MD & Associates
Northfield, Illinois, 60093
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, 60181
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, 73118
Medical Research Group of Central Florida
Orange City, Florida, 32763
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Vince & Associates Clinical Research
Overland Park, Kansas, 66211
Pedia Research, LLC
Owensboro, Kentucky, 42301
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Pivotal Research Center
Peoria, Arizona, 85381
CNS Research Institute
Philadelphia, Pennsylvania, 19149
Richard Weisler, MD and Associates
Raleigh, North Carolina, 27609
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Pharmacology Research Institute
Riverside, California, 92506
Capital Clinical Research Associates
Rockville, Maryland, 20852
Dupont Clinical Research
Rockville, Maryland, 20852
Regions Hospital - Department of Behavioral Health
Saint Paul, Minnesota, 55101
University of Utah Mood Disorders Clinic
Salt Lake City, Utah, 84132
Croft Group Research Center
San Antonio, Texas, 78229
Clinical Innovations, Inc.
Santa Ana, California, 92705
Roskamp Institute, Clinical Trials Division
Sarasota, Florida, 34243
LSU Health Science Center
Shreveport, Louisiana, 71103
Behavioral Medical Research of Staten Island
Staten Island, New York, 10305
Stedman Clinical Trials
Tampa, Florida, 33613
Center for Psychopharmacologic Research and Treatment
Worcester, Massachusetts, 01605
Canada6 sites
University of Alberta
Edmonton, Alberta, T6G 2C8
Mood Disorders Clinic
Hamilton, Ontario, L8N 3Z5
Clinique Marie-Fitzbach,
Québec, Quebec, GIR 2W8
Center for Addiction and Mental Health, Mood and Anxiety Program
Toronto, Ontario, M5T 1R8
University of British Columbia, Vancouver
Vancouver, British Columbia, V6T 2A1
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Gabitril at 4, 8, and 12 mg/Day in the Treatment of Adults With Generalized Anxiety Disorder.
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).
- Conditions
- Anxiety Disorder
- Being tested
- Gabitril
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabitrilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to end point in the total score of the HAM-A scale.
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startNov 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 880 participants
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236015
- Sponsor's protocol ID
- C6671/3030/AX/US
- Status last verified
- May 2014
- First submitted
- 7 Oct 2005
- Last updated
- 9 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Gabitril at 4, 8, and 12 mg/Day in the Treatment of Adults With Generalized Anxiety Disorder.
- ClinicalTrials.gov ID
- NCT00236015
- Acronym / sponsor ID
- C6671/3030/AX/US
- Conditions
- Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Mar 2006
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabitril | Drug | – |
Primary outcome
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to end point in the total score of the HAM-A scale.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
Related trials for Anxiety Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
54 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabitril in people with Anxiety Disorder, run by Cephalon at 54 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to end point in the total score of the HAM-A scale.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.