Social PhobiaPhase 1NCT00470483
A Study To Compare Emotional Changes In Subjects With Social Anxiety Disorder
A Phase 1 study testing Paroxetine treatment during 8 weeks in people with Social Phobia, run by GlaxoSmithKline at 1 site in Spain.
Trial summary
To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Phobia
- What is being tested?
- Paroxetine treatment during 8 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2007to 7 Jan 2009
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Outpatient with Social Anxiety Disorder
- The subject is healthy
- Willing to restrict alcohol intake
- Capable of giving informed consent
Who cannot join
- Subjects with depression or any other psychiatric condition
- Subjects positive for HIV or hepatitis
- Subjects taking drugs or other medication
- Pregnant or becoming pregnant during the study
- Subjects who have donated blood
- Subjects who are left-handed
- Subjects with claustrophobia
- Subjects with an electronic device or ferromagnetic metal foreign body
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, fMRI and PET Study Comparing Emotional Challenge-induced Regional Cerebral Blood Flow Changes Before and After 8 Weeks of Treatment With Placebo and Paroxetine in Subjects With Social Anxiety Disorder
To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration
- Conditions
- Social Phobia
- Being tested
- Placebo treatment during 8 weeks, Paroxetine treatment during 8 weeks
- Keywords
- PET, Social Anxiety Disorder, fRMI
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo treatment during 8 weeksDrug
comparator
Paroxetine treatment during 8 weeksDrug
Also called Placebo treatment during 8 weeks
treatment drug
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | Active comparator | Paroxetine treatment during 8 weeks Receives: Drug: Paroxetine treatment during 8 weeks |
| arm 2 | Placebo comparator | Placebo treatment during 8 weeks Receives: Drug: Placebo treatment during 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI BOLD response in the amygdala and insula elicited by the Matching Emotional Face paradigm at baseline and after 8 weeks of treatment. State-anxiety inventory (STAI-S) after the Public Speaking challenge (only patients).
Measured: baseline and after 8 weeks
Secondary outcomes (1)
fMRI BOLD response in selected neuroanatomical ROI elicited by the by Resting State and by other exploratory paradigms at baseline (all subjects) and after 8 weeks of treatment with paroxetine compared to placebo (only patients).
Measured: baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study start22 Jan 2007
- Primary completion7 Jan 2009
- Study completion7 Jan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470483
- Sponsor's protocol ID
- TMT106386
- Status last verified
- Jul 2017
- First submitted
- 3 May 2007
- Last updated
- 18 Jul 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, fMRI and PET Study Comparing Emotional Challenge-induced Regional Cerebral Blood Flow Changes Before and After 8 Weeks of Treatment With Placebo and Paroxetine in Subjects With Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00470483
- Acronym / sponsor ID
- TMT106386
- Conditions
- Social Phobia
- Keywords
- PET, Social Anxiety Disorder, fRMI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2007 (actual)
- Primary completion
- 7 Jan 2009 (actual)
- Study completion
- 7 Jan 2009 (actual)
- First posted
- 7 May 2007 (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.
To compare by neuroimaging techniques the way Social Anxiety patients respond to public speaking before and after a drug administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Active comparator | Drug: Paroxetine treatment during 8 weeksParoxetine treatment during 8 weeks |
| arm 2 | Placebo comparator | Drug: Placebo treatment during 8 weeksPlacebo treatment during 8 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Outpatient with Social Anxiety Disorder
- The subject is healthy
- Willing to restrict alcohol intake
- Capable of giving informed consent
Key exclusion criteria (8 listed)
- Subjects with depression or any other psychiatric condition
- Subjects positive for HIV or hepatitis
- Subjects taking drugs or other medication
- Pregnant or becoming pregnant during the study
- Subjects who have donated blood
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 |
|---|---|---|
| Placebo treatment during 8 weekscomparator | Drug | arm 2 |
| Paroxetine treatment during 8 weeksAlso: Placebo treatment during 8 weekstreatment drug | Drug | arm 1 |
Primary outcome
fMRI BOLD response in the amygdala and insula elicited by the Matching Emotional Face paradigm at baseline and after 8 weeks of treatment. State-anxiety inventory (STAI-S) after the Public Speaking challenge (only patients).
Time frame: baseline and after 8 weeks
1 secondary outcome
fMRI BOLD response in selected neuroanatomical ROI elicited by the by Resting State and by other exploratory paradigms at baseline (all subjects) and after 8 weeks of treatment with paroxetine compared to placebo (only patients).
Time frame: baseline and after 8 weeks
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 18 Jul 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study TMT106386 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paroxetine treatment during 8 weeks in people with Social Phobia, run by GlaxoSmithKline at 1 site in Spain.
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 8 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 18 Jul 2017. 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 Spain. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
fMRI BOLD response in the amygdala and insula elicited by the Matching Emotional Face paradigm at baseline and after 8 weeks of treatment. State-anxiety inventory (STAI-S) after the Public Speaking challenge (only patients). (time frame: baseline and after 8 weeks). 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 18 Jul 2017.