Social Anxiety Disorder (SAD)Phase 4NCT00231348
Nefazodone in the Treatment of Social Phobia
A Phase 4 study testing Nefazodone in people with Social Anxiety Disorder (SAD), run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder (SAD)
- What is being tested?
- Nefazodone
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Apr 2000
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of generalized social anxiety disorder, males and females between the ages of 18-65
Who cannot join
- A history of bipolar disorder, psychotic illness, or any other anxiety disorders, organic brain disease or active drug or alcohol abuse within one year as assessed by the SCID-P and interview, or a concurrent medical condition that would not be compatible with the study in the opinion of the principal investigator. Patients required to be free of psychotropic or beta-blocker medication for 2 weeks prior to study. Pts taking fluoxetine required to be drug-free for 6 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Depatment of Psychiatry and Behavioral Sciences
Atlanta, Georgia, 30322
About this study
Official title: Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates
The purpose of this study is to determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).
Read the detailed description
The purpose of this study is to examine the efficacy of the 5HT2 receptor antagonist nefazadone in SAD, and to explore regional cerebral blood flow in patients with SAD when confronted with a personal phobic stimulus, using positron emission tomography (PET). Changes in cerebral blood flow were correlated with self-rated anxiety measures.
- Conditions
- Social Anxiety Disorder (SAD)
- Being tested
- Nefazodone
- Keywords
- Social anxiety disorder, social phobia, positron emission tomography (PET, regional cerebral blood flow (rCBF), nefazodone, amygdala
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefazodoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety Disorder (SAD)Studies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Charles B Nemeroff, MD, PhD, Principal investigator, Emory University Department of Psychiatry and Behavioral SciencesClinton D Kilts, PhD, Study director, Emory University Department of Psychiatry and Behavioral SciencesJeffrey Newport, MD, Study director, Emory University Department of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231348
- Sponsor's protocol ID
- 0707-1997
- Status last verified
- Nov 2013
- First submitted
- 3 Oct 2005
- Last updated
- 13 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nefazodone in the Treatment of Social Phobia: Functional Brain Imaging and Neuroendocrine Correlates
- ClinicalTrials.gov ID
- NCT00231348
- Acronym / sponsor ID
- 0707-1997
- Conditions
- Social Anxiety Disorder (SAD)
- Keywords
- Social anxiety disorder, social phobia, positron emission tomography (PET, regional cerebral blood flow (rCBF), nefazodone, amygdala
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study completion
- Apr 2000 (actual)
- First posted
- 4 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 determine the effectiveness of nefazadone in patients with social anxiety disorder (SAD).
Detailed description
The purpose of this study is to examine the efficacy of the 5HT2 receptor antagonist nefazadone in SAD, and to explore regional cerebral blood flow in patients with SAD when confronted with a personal phobic stimulus, using positron emission tomography (PET). Changes in cerebral blood flow were correlated with self-rated anxiety measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DSM-IV diagnosis of generalized social anxiety disorder, males and females between the ages of 18-65
Key exclusion criteria (1 listed)
- A history of bipolar disorder, psychotic illness, or any other anxiety disorders, organic brain disease or active drug or alcohol abuse within one year as assessed by the SCID-P and interview, or a concurrent medical condition that would not be compatible with the study in the opinion of the principal investigator. Patients required to be free of psychotropic or beta-blocker medication for 2 weeks prior to study. Pts taking fluoxetine required to be drug-free for 6 weeks.
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 |
|---|---|---|
| Nefazodone | Drug | – |
Primary outcome
Not reported in the source record.
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 13 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.
Charles B Nemeroff, MD, PhD principal investigator
Emory University Department of Psychiatry and Behavioral Sciences
Clinton D Kilts, PhD study director
Emory University Department of Psychiatry and Behavioral Sciences
Jeffrey Newport, MD study director
Emory University Department of Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nefazodone in people with Social Anxiety Disorder (SAD), run by Emory University at 1 site 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 13 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 1 site 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.
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 13 Nov 2013.