Anxiety DisorderPhase 3NCT00097708
Experimental Medication For the Treatment of Generalized Anxiety Disorder
A Phase 3 study testing experimental anti-anxiety drug in people with Anxiety Disorder, run by Jazz Pharmaceuticals at 50 sites in United States.
Trial summary
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorder
- What is being tested?
- experimental anti-anxiety drug
- How many people
- 511 participants
- Where
- 50 sitesUnited States
- Study dates
- Nov 2004to Dec 2005
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.
Who cannot join
- No other primary psychiatric diagnosis besides GAD.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United States50 sites
Crest Clinical Trials, Inc.
Anaheim, California, 92804
FutureSearch Trials
Austin, Texas, 78756
Pharmasite Research, Inc.
Baltimore, Maryland, 21208
Northwest Clinical Research Center
Bellevue, Washington, 98004
McLean Hospital
Belmont, Massachusetts, 02478
Southwesten Research, Inc.
Beverly Hills, California, 90210
Birmingham Research Group, Inc.
Birmingham, Alabama, 35216
Radiant Research
Boise, Idaho, 83704
Alpine Clinical Research Center
Boulder, Colorado, 80304
Florida Clinical Research Center
Bradenton, Florida, 34208
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Southwestern Research Institute
Burbank, California, 91506
Southeast Health Consultants, LLC
Charleston, South Carolina, 29407
CNS Research Institute (CRI)
Clementon, New Jersey, 08021
Research Across America
Dallas, Texas, 75234
Midwest Clinical Research Center
Dayton, Ohio, 45408
ACT Clinical Research
DeLand, Florida, 32720
University Clinical Research DeLand, Inc.
DeLand, Florida, 32720
Oregon Center for Clinical Investigations, Inc.
Eugene, Oregon, 97401
Comprehensive Neuroscience of Northern Virginia
Falls Church, Virginia, 22041
Sarkis Clinical Trials
Gainsville, Florida, 32607
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
ClinSearch, Inc.
Kenilworth, New Jersey, 07033
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Atlanta Institute of Medicine and Research
Marietta, Georgia, 30060
Suburban Research Associates
Media, Pennsylvania, 19063
CNS, Inc.
Memphis, Tennessee, 38119
New Orlean Medical Institute
Metairie, Louisiana, 70001
Dominion Clinical Research, Inc.
Midlothian, Virginia, 23112
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
New Britain General Hospital
New Britain, Connecticut, 06050
American Medical Research, Inc.
Oak Brook, Illinois, 60523
IPS Research Company
Oklahoma City, Oklahoma, 73103
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Peak Medical Research, LLC
Owensboro, Kentucky, 42303
CNS Research Institute
Philadelphia, Pennsylvania, 19149
Princeton Medical Institute
Princeton, New Jersey, 08540
Pivotal Research Centers - Detroit
Royal Oak, Michigan, 48073
Lifetree Clinical Research
Salt Lake City, Utah, 84106
University of California - San Diego - Dept of Psychiatry
San Diego, California, 92103
Clinical Innovations
Santa Ana, California, 92705
Brentwood Research Institute
Shreveport, Louisiana, 71101
MedClin Research
St Louis, Missouri, 63118
Meridien Research
St. Petersburg, Florida, 33709
Stanford University Medical Center
Stanford, California, 94305
Institute of Research in Psychiatry
Tampa, Florida, 33613
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, 43623
Laureate Psychiatric Clinic and Hospital
Tulsa, Oklahoma, 74136
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
About this study
Official title: A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
Read the detailed description
Protocol 04-001-01
The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).
The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.
Recruiting: Participants are currently being recruited and enrolled.
- Conditions
- Anxiety Disorder
- Being tested
- experimental anti-anxiety drug
- Keywords
- Double Blind, Placebo controlled, Safety and Efficacy, Generalized Anxiety Disorder
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental anti-anxiety drugDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HAM-A Total Score
Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.
Measured: Baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2004 (estimated)
- Study startNov 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- 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
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Murray Stein, MD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097708
- Sponsor's protocol ID
- JZP 04-001-01
- Status last verified
- Oct 2014
- First submitted
- 29 Nov 2004
- Last updated
- 3 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00097708
- Acronym / sponsor ID
- JZP 04-001-01
- Conditions
- Anxiety Disorder
- Keywords
- Double Blind, Placebo controlled, Safety and Efficacy, Generalized Anxiety Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Dec 2005
- First posted
- 30 Nov 2004 (estimated)
- Results
- Posted 3 Oct 2014
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 determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
Detailed description
Protocol 04-001-01
The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).
The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.
Recruiting: Participants are currently being recruited and enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.
Key exclusion criteria (1 listed)
- No other primary psychiatric diagnosis besides GAD.
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 |
|---|---|---|
| experimental anti-anxiety drug | Drug | – |
Primary outcome
Change in HAM-A Total Score
Time frame: Baseline to week 8
Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Murray Stein, MD study chair
University of California, San Diego
50 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 experimental anti-anxiety drug in people with Anxiety Disorder, run by Jazz Pharmaceuticals at 50 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 1 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 3 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 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?
Yes. Results are posted in the registry (first posted 3 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in HAM-A Total Score (time frame: Baseline to week 8). 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 3 Oct 2014.