Efficacy of Adding Topiramate to Current Treatment in Tre... | NCT00182455

Studies
Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)

NCT00182455

Sponsor

McMaster University

Status

Terminated

Last Update Posted

Sep 2, 2020Actual

Enrollment

12Estimated

Phase

Phase 4

Conditions

Social Phobia

Interventions

Topiramate
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

loss of funding

Expanded Access Info

Start Date

Mar 1, 2004Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 1, 2018Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2020

Last Update Posted Date

Sep 2, 2020Actual

Name	Class
Janssen-Ortho Inc., Canada	INDUSTRY
Hamilton Health Sciences Corporation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Topiramate 25 - 400 mg/day x 12 weeks	Drug: Topiramate
2	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Topiramate	Drug	25 - 400 mg/day x 12 weeks	1	Topomax

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Global Impression - Improvement (CGI-I) ≤ 2		12 weeks
Mean change in Liebowitz Social Anxiety Scale (LSAS)		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Social Phobia Scale		12 weeks
Social Phobia Inventory		12 weeks
Clinical Global Impression -Severity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Van Ameringen, MD, FRCPC	Hamilton Health Sciences Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MacAnxiety Research Centre		Hamilton	Ontario	L8S 1B7	Canada

ID	Term
D010698	Phobic Disorders
D001008	Anxiety Disorders
D001523	Mental Disorders

ID	Term
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241