Social PhobiaPhase 4NCT00182455
Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)
A Phase 4 study testing Topiramate in people with Social Phobia, run by McMaster University at 1 site in Canada.
Trial summary
SSRI's are considered first-line treatments for GSP, however many patients continue to have significant symptoms despite an adequate trial of an SSRI. Topiramate, a drug, which targets the glutamate system in the brain, has been shown to improve symptoms of social phobia when used on its own and has also been used as… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- Topiramate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2004to 1 Dec 2018
- 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
- Outpatient with primary DSM-IV GSP
- Completion of an adequate trial (14 wks) of open, flexible dose SSRI treatment (fluoxetine 80mg/day, paroxetine 60mg/day, fluvoxamine 300 mg/day, sertraline 200mg/day, citalopram 60mg/day, escitalopram 30mg/day)
- Non or partial response to SSRI treatment (CGI-S > 4, LSAS > 40)
Who cannot join
- Any other DSM-IV Axis I primary diagnosis
- Meeting DSM-IV criteria for body dysmorphic disorder, eating disorder or current alcohol/substance abuse
- A lifetime history of bipolar affective disorder
- A Hx of schizophrenia/psychotic disorders, delirium, dementia, or amnestic/other cognitive disorders
- Borderline/antisocial personality disorder
- A comorbid Axis II cluster A personality disorder
Show all 14Show fewer
- Hx of > 3 adequate trials with an SSRI
- score of > 4 on MADRS q.10
- Current increased risk of suicide
- Prior use of or an allergy to topiramate
- Participation in any clinical trial 30 days prior to entering the study
- Unable to tolerate being free of or shows signs of withdrawal benzodiazepines for 4 weeks
- Hx of seizures, kidney stones or thyroid problems
- BMI < 20
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.
SSRI's are considered first-line treatments for GSP, however many patients continue to have significant symptoms despite an adequate trial of an SSRI. Topiramate, a drug, which targets the glutamate system in the brain, has been shown to improve symptoms of social phobia when used on its own and has also been used as an additive treatment in other anxiety disorders. This study will test the efficacy of adding topiramate to a subject's current SSRI in cases of GSP which are considered to be treatment-resistant.
- Conditions
- Social Phobia
- Being tested
- Topiramate, Placebo
- Keywords
- Treatment Refractory Generalized Social Phobia
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Also called Topomax
25 - 400 mg/day x 12 weeks
PlaceboDrug
25 - 400 mg/day x 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Topiramate 25 - 400 mg/day x 12 weeks Receives: Drug: Topiramate |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression - Improvement (CGI-I) ≤ 2
Measured: 12 weeks
Mean change in Liebowitz Social Anxiety Scale (LSAS)
Measured: 12 weeks
Secondary outcomes (7)
Social Phobia Scale
Measured: 12 weeks
Social Phobia Inventory
Measured: 12 weeks
Clinical Global Impression -Severity
Measured: 12 weeks
Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale
Measured: 12 weeks
Montgomery Asberg Depression Rating Scale
Measured: 12 weeks
Beck Depression Inventory
Measured: 12 weeks
Beck Anxiety Inventory
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start1 Mar 2004
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Why it stopped: loss of funding
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 McMaster 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Ortho Inc., Canada, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Michael Van Ameringen, MD, FRCPC, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182455
- Sponsor's protocol ID
- 04-080
- Status last verified
- Apr 2018
- First submitted
- 14 Sep 2005
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.
- ClinicalTrials.gov ID
- NCT00182455
- Acronym / sponsor ID
- 04-080
- Conditions
- Social Phobia
- Keywords
- Treatment Refractory Generalized Social Phobia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: loss of funding
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Janssen-Ortho Inc., Canada, Hamilton Health Sciences Corporation
- Study start
- 1 Mar 2004 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 16 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.
SSRI's are considered first-line treatments for GSP, however many patients continue to have significant symptoms despite an adequate trial of an SSRI. Topiramate, a drug, which targets the glutamate system in the brain, has been shown to improve symptoms of social phobia when used on its own and has also been used as an additive treatment in other anxiety disorders. This study will test the efficacy of adding topiramate to a subject's current SSRI in cases of GSP which are considered to be treatment-resistant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TopiramateTopiramate 25 - 400 mg/day x 12 weeks |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatient with primary DSM-IV GSP
- Completion of an adequate trial (14 wks) of open, flexible dose SSRI treatment (fluoxetine 80mg/day, paroxetine 60mg/day, fluvoxamine 300 mg/day, sertraline 200mg/day, citalopram 60mg/day, escitalopram 30mg/day)
- Non or partial response to SSRI treatment (CGI-S > 4, LSAS > 40)
Key exclusion criteria (14 listed)
- Any other DSM-IV Axis I primary diagnosis
- Meeting DSM-IV criteria for body dysmorphic disorder, eating disorder or current alcohol/substance abuse
- A lifetime history of bipolar affective disorder
- A Hx of schizophrenia/psychotic disorders, delirium, dementia, or amnestic/other cognitive disorders
- Borderline/antisocial personality disorder
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 |
|---|---|---|
| TopiramateAlso: Topomax25 - 400 mg/day x 12 weeks | Drug | 1 |
| Placebo25 - 400 mg/day x 12 weeks | Drug | 2 |
Primary outcome
Clinical Global Impression - Improvement (CGI-I) ≤ 2
Time frame: 12 weeks
Mean change in Liebowitz Social Anxiety Scale (LSAS)
Time frame: 12 weeks
7 secondary outcomes
Social Phobia Scale
Time frame: 12 weeks
Social Phobia Inventory
Time frame: 12 weeks
Clinical Global Impression -Severity
Time frame: 12 weeks
Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale
Time frame: 12 weeks
Montgomery Asberg Depression Rating Scale
Time frame: 12 weeks
Beck Depression Inventory
Time frame: 12 weeks
Beck Anxiety Inventory
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
Michael Van Ameringen, MD, FRCPC principal investigator
Hamilton Health Sciences Corporation
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 Topiramate in people with Social Phobia, run by McMaster University at 1 site in Canada.
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 14 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: stopped early, as of the sponsor's last update on 2 Sep 2020. 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 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. 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 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 was stopped early (reason given: loss of funding). Results are not available in the source record.
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?
Clinical Global Impression - Improvement (CGI-I) ≤ 2 (time frame: 12 weeks). 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 2 Sep 2020.