Social Anxiety DisorderPhase 4NCT00208741
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder
A Phase 4 study testing Gabitril in people with Social Anxiety Disorder, run by Emory University at 3 sites in United States.
Trial summary
The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Gabitril
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2002to Nov 2003
- Phase
- Phase 4
- 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
- Primary diagnosis of SAD
- CGI (S) ≥ 4 at screen
- LSAS ≥ 50 at baseline
- Covi Anxiety Scale score greater than the Raskin depression Scale total score at screen
Who cannot join
- Non-responsive to adequate trials of two or more treatment medications, if previously treated for SAD.
- HAM-D ≥15 or a score of >2 on Item 1 at baseline
- Serious or unstable medical condition
- Alcohol or substance use disorder within 6 months prior to study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University School of Medicine
Atlanta, Georgia, 30329
Hillside Hospital of the North Shore-Long Island Jewish Health System
Long Island City, New York, 10032
Columbia/New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: A 12-Week Open-Label Study Followed By A 24-Week Double-Blind Discontinuation Exploratory Study To Evaluate The Effects Of Gabitril™ (Tiagabine Hydrochloride) In Patients With Social Anxiety Disorder (SAD)
The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).
Read the detailed description
This study is being conducted at two sites in the United States. Approximately 50 patients, who are between the ages of 18 and 65 years old will be enrolled at Emory. This study consists of two parts. The first part consists of 12 weeks of open-label treatment with Gabitril. If the study doctor determines that the patients condition has improved and they have completed the initial 12 weeks of treatment they may be eligible for the second part of the study. This part is a 24-week double-blind treatment period with either Gabitril or placebo (inactive medication). There will also be a follow-up visit about 1 to 3 weeks after they have completed taking the study medication. Altogether study participation is expected to last approximately 37 weeks.
- Conditions
- Social Anxiety Disorder
- Being tested
- Gabitril
- Keywords
- Social Anxiety Disorder, Mental Health
- Medical subject headings
- Phobia, Social, Psychological Well-Being
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.
Liebowitz Social Anxiety Scale (LSAS)
Clinical Global Impression-Change (CGI-C)
Secondary outcomes (5)
Hamilton Anxiety Scale (HAM-A)
Social Phobia Inventory (SPIN)
Pittsburgh Sleep Quality Index (PSQI)
36-Item Short-Form Health Survey (SF-36)
Clinical Global Impression-S (CGI-S).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2002
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Philip T Ninan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208741
- Sponsor's protocol ID
- 0337-2002
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 11 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week Open-Label Study Followed By A 24-Week Double-Blind Discontinuation Exploratory Study To Evaluate The Effects Of Gabitril™ (Tiagabine Hydrochloride) In Patients With Social Anxiety Disorder (SAD)
- ClinicalTrials.gov ID
- NCT00208741
- Acronym / sponsor ID
- 0337-2002
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety Disorder, Mental Health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Jun 2002
- Study completion
- Nov 2003
- First posted
- 21 Sep 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 main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).
Detailed description
This study is being conducted at two sites in the United States. Approximately 50 patients, who are between the ages of 18 and 65 years old will be enrolled at Emory. This study consists of two parts. The first part consists of 12 weeks of open-label treatment with Gabitril. If the study doctor determines that the patients condition has improved and they have completed the initial 12 weeks of treatment they may be eligible for the second part of the study. This part is a 24-week double-blind treatment period with either Gabitril or placebo (inactive medication). There will also be a follow-up visit about 1 to 3 weeks after they have completed taking the study medication. Altogether study participation is expected to last approximately 37 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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 (4 listed)
- Primary diagnosis of SAD
- CGI (S) ≥ 4 at screen
- LSAS ≥ 50 at baseline
- Covi Anxiety Scale score greater than the Raskin depression Scale total score at screen
Key exclusion criteria (4 listed)
- Non-responsive to adequate trials of two or more treatment medications, if previously treated for SAD.
- HAM-D ≥15 or a score of >2 on Item 1 at baseline
- Serious or unstable medical condition
- Alcohol or substance use disorder within 6 months prior to study
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
Liebowitz Social Anxiety Scale (LSAS)
Clinical Global Impression-Change (CGI-C)
5 secondary outcomes
Hamilton Anxiety Scale (HAM-A)
Social Phobia Inventory (SPIN)
Pittsburgh Sleep Quality Index (PSQI)
36-Item Short-Form Health Survey (SF-36)
Clinical Global Impression-S (CGI-S).
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 11 Nov 2013.
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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.
Philip T Ninan, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabitril in people with Social Anxiety Disorder, run by Emory University at 3 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 4 inclusion and 4 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 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Liebowitz Social Anxiety Scale (LSAS). The study lists 2 primary outcomes in all. 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 11 Nov 2013.