Anxiety DisordersPhase 2NCT00108836
Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder
A Phase 2 study testing XBD173 in people with Anxiety Disorders, run by Novartis Pharmaceuticals at 23 sites in 2 countries.
Trial summary
This study will test the efficacy, safety and tolerability of XBD173 in the treatment of generalized anxiety disorder in patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- XBD173
- How many people
- 400 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Mar 2005to May 2006
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current doctor's diagnosis of generalized anxiety disorder
- In need of psychiatric treatment
- Willingness to complete all aspects of the study
Who cannot join
- Current doctor's diagnosis of major depression
- History of schizophrenia or schizoaffective disorders
- Drug dependence within 2 months prior to study start
- For detailed information on eligibility, please contact the study center nearest to you (see below), or call 1-862-778-8300, or visit the following website:
- www.novartisclinicaltrials.com
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States16 sites
Investigational Site
Anaheim, California, 92801
Investigational Site
Atlanta, Georgia, 30308
Investigational Site
Dayton, Ohio, 45408
Investigational Site
Fort Meyers, Florida, 33712
Investigational Site
Hoffman Estates, Illinois, 60194
Investigational Site
Los Angeles, California, 90024
Investigational Site
Madison, Tennessee, 37115
Investigational Site
Memphis, Tennessee, 38119
Investigational Site
Newport Beach, California, 92660
Investigational Site
Oak Brook, Illinois, 60523
Investigational Site
Overland Park, Kansas, 66211
Investigational Site
Portland, Oregon, 97239
Investigational Site
Redlands, California, 92374
Investigational Site
San Diego, California, 92108
Investigational Site
St. Petersburg, Florida, 33702
Investigational Site
West Palm Beach, Florida, 33407
Canada7 sites
Investigational Site
Edmonton, Alberta, T6G 2C8
Investigational Site
Hamilton, Ontario, 3Z5
Investigational Site
Kelowna, British Columbia, V1Y 2H4
Investigational Site
Montreal, Quebec, 2N6
Investigational Site
Ottawa, Ontario, 7K4
Investigational Site
Sherbrooke, Quebec, 4J6
Investigational Site
Toronto, Ontario, 1R8
About this study
This study will test the efficacy, safety and tolerability of XBD173 in the treatment of generalized anxiety disorder in patients.
- Conditions
- Anxiety Disorders
- Being tested
- XBD173
- Keywords
- GAD, Anxiety, XBD173, 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.
XBD173Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction in anxiety from baseline to week 6
Secondary outcomes (5)
The difference on day 4 in effect between placebo and the individual doses of XBD173 on reduction in anxiety and depression
Pharmacokinetic assessments at baseline
Pharmacogenetic assessments at baseline
Pharmacogenomic and proteomic assessments at baseline
Metabonomic assessments at visits 4, 7 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2005 (estimated)
- Study startMar 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Novartis 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108836
- Sponsor's protocol ID
- CXBD173A2204
- Status last verified
- Nov 2007
- First submitted
- 19 Apr 2005
- Last updated
- 20 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability of XBD173 in Patients With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00108836
- Acronym / sponsor ID
- CXBD173A2204
- Conditions
- Anxiety Disorders
- Keywords
- GAD, Anxiety, XBD173, Generalized Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- May 2006 (actual)
- First posted
- 20 Apr 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.
This study will test the efficacy, safety and tolerability of XBD173 in the treatment of generalized anxiety disorder in patients.
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 (3 listed)
- Current doctor's diagnosis of generalized anxiety disorder
- In need of psychiatric treatment
- Willingness to complete all aspects of the study
Key exclusion criteria (5 listed)
- Current doctor's diagnosis of major depression
- History of schizophrenia or schizoaffective disorders
- Drug dependence within 2 months prior to study start
- For detailed information on eligibility, please contact the study center nearest to you (see below), or call 1-862-778-8300, or visit the following website:
- www.novartisclinicaltrials.com
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 |
|---|---|---|
| XBD173 | Drug | – |
Primary outcome
Mean reduction in anxiety from baseline to week 6
5 secondary outcomes
The difference on day 4 in effect between placebo and the individual doses of XBD173 on reduction in anxiety and depression
Pharmacokinetic assessments at baseline
Pharmacogenetic assessments at baseline
Pharmacogenomic and proteomic assessments at baseline
Metabonomic assessments at visits 4, 7 and 10
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 20 May 2010.
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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.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XBD173 in people with Anxiety Disorders, run by Novartis Pharmaceuticals at 23 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 3 inclusion and 5 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 20 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean reduction in anxiety from baseline to week 6. 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 20 May 2010.