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

Social Phobia Clinical Trial

Official title:

Topiramate Augmentation to a Selective Serotonin Re-uptake Inhibitor (SSRI) in Treatment-Resistant Generalized Social Phobia: A Double-Blind Placebo -Controlled Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00182455
• Other study ID #: 04-080
• Status: Terminated
• Phase: Phase 4
• Start date: March 1, 2004
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Phobia, Social
• Phobic Disorders
• Social Phobia

Intervention

Drug:
• Topiramate
25 - 400 mg/day x 12 weeks
• Placebo
25 - 400 mg/day x 12 weeks

Locations

Country	Name	City	State
Canada	MacAnxiety Research Centre	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation, Janssen-Ortho Inc., Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression - Improvement (CGI-I) = 2		12 weeks
Primary	Mean change in Liebowitz Social Anxiety Scale (LSAS)		12 weeks
Secondary	Social Phobia Scale		12 weeks
Secondary	Social Phobia Inventory		12 weeks
Secondary	Clinical Global Impression -Severity		12 weeks
Secondary	Quality of life and Employment Satisfaction Questionnaire Sheehan Disability Scale		12 weeks
Secondary	Montgomery Asberg Depression Rating Scale		12 weeks
Secondary	Beck Depression Inventory		12 weeks
Secondary	Beck Anxiety Inventory		12 weeks