Generalized Anxiety DisorderPhase 3NCT00236054
A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
A Phase 3 study testing Gabitril in people with Generalized Anxiety Disorder, run by Cephalon at 19 sites in United States.
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
- Generalized Anxiety Disorder
- What is being tested?
- Gabitril
- How many people
- 440 participants
- Where
- 19 sitesUnited States
- Study dates
- Oct 2004to Dec 2005
- 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 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Atlanta Institute of Medicine & Research - Atlanta Clinic
Atlanta, Georgia, 30328
Northwest Clinical Research Center
Bellevue, Washington, 98004
Social Psychiatry Research Inst.
Brooklyn, New York, 11235
Northbrooke Research
Brown Deer, Wisconsin, 53223
South East Health Consultants, LLC
Charleston, South Carolina, 29407
Hartford Research Group Ltd.
Cincinnati, Ohio, 45242
Cunningham Clinical Research, LLC
Edwardsville, Illinois, 62025
Summit Research Network
Farmington Hills, Michigan, 48336
UF Behavioral Health Clinic
Jacksonville, Florida, 32257
Pacific Institute for Medical Research, Inc.
Los Angeles, California, 90024
LSUHSC Anxiety and Mood Disorders Clinic
New Orleans, Louisiana, 70115
Eastside Comprehensive Medical Center
New York, New York, 10021
Medical and Behavioral Health Research, PC
New York, New York, 10023
Pharmacology Research Institute
Newport Beach, California, 92660
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon, 97301
Affiliated Research Institute
San Diego, California, 92108
Health Quest Clinical Trials
San Diego, California, 92123
Pacific Clinical Research Medical Group
Upland, California, 91786
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
About this study
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
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
- Generalized Anxiety Disorder
- Being tested
- Gabitril
- Medical subject headings
- Generalized Anxiety Disorder
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 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
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 startOct 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 440 participants
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236054
- Sponsor's protocol ID
- C6671/3032/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, 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
- ClinicalTrials.gov ID
- NCT00236054
- Acronym / sponsor ID
- C6671/3032/AX/US
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Dec 2005
- 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
- Primary purpose
- Treatment
- 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 the past 3 months
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 endpoint in the total score of the HAM-A scale.
3 secondary outcomes
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.
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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.
19 sites in 1 country: 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 Generalized Anxiety Disorder, run by Cephalon at 19 sites in United States.
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 19 sites in United States. 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 endpoint 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.