Official Title: “Sertraline in the Treatment of Generalized Social Phobia With Comorbidity”

Selective serotonin reuptake inhibitors (SSRIs) including sertraline have been found to be effective in the treatment of generalized social phobia (GSP). However, virtually all of the current treatment studies with medicines, including the SSRIs, have excluded patients with social phobia who have other co-occurring conditions. In fact, 80% of individuals suffering with primary social phobia have at least one other anxiety. This study will evaluate the safety and efficacy of sertraline in the treatment of generalized social phobia with co-occurring anxiety and mood disorders.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: Sertraline
  • 25 - 200 mg/day x 16 weeks
• Drug: Placebo
  • 25 - 200 mg/day x 16 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Sertraline
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Clinical Global Impression - Improvement ≤ 2
  • Time Frame: 16 weeks
    Safety Issue?: No
• Liebowitz Social Anxiety Scale [LSAS] (mean change from baseline)
  • Time Frame: 16 weeks
    Safety Issue?: No

Secondary Measures

• Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire
  • Time Frame: 16 weeks
    Safety Issue?: No
• Sheehan Disability Scale
  • Time Frame: 16 weeks
    Safety Issue?: No
• Social Phobia Scale
  • Time Frame: 16 weeks
    Safety Issue?: No
• Brief Social Phobia Scale
  • Time Frame: 16 weeks
    Safety Issue?: No
• Penn State Worry Questionnaire
  • Time Frame: 16 weeks
    Safety Issue?: No
• Panic and Agoraphobia Scale
  • Time Frame: 16 weeks
    Safety Issue?: No
• Davidson Trauma Scale
  • Time Frame: 16 weeks
    Safety Issue?: No
• Social Anxiety Spectrum Self-Report (SHY-SR)
  • Time Frame: 16 weeks
    Safety Issue?: No
• Yale-Brown Obsessive Compulsive Scale
  • Time Frame: 16 weeks
    Safety Issue?: No
• Montgomery-Asberg Depression Rating Scale (MADRS)
  • Time Frame: 16 weeks
    Safety Issue?: No

Inclusion Criteria:

• Outpatient with primary Diagnostic and Statistical Manual of Mental Disorders, 4th
• Edition (DSM-IV) GSP plus at least one of the following comorbid DSM-IV anxiety disorders: panic disorder with agoraphobia, obsessive compulsive disorder, major depressive disorder, generalized anxiety disorder
• Score on LSAS > 50
• Score on MADRS < 25

Exclusion Criteria:

• Any other primary AXIS-I diagnosis
• Criteria for alcohol/substance abuse/dependence
• History (Hx) of bipolar disorder, schizophrenia or other psychotic disorder
• A comorbid Axis II cluster A personality disorder
• Current increased risk of concomitant suicide
• Allergy/previous intolerance during an adequate trial (50mg/day for minimum of 4 weeks) of sertraline
• Participation in any clinical trial 30 days prior to entering the study
• Unable to tolerate being free of/shows signs of withdrawal from benzodiazepines for 4 weeks
• Hx of seizures
• Thyroid problems

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hamilton Health Sciences

Overall Clinical Trial Officials and Contacts

Michael Van Ameringen, MD, FRCPC Principal Investigator Hamilton Health Sciences  

Overall Contact: Beth Patterson, BScN, BEd 905-521-2100 beth@macanxiety.com

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00182533

Study ID Number: 02-195

ClinicalTrials.gov Identifier: NCT00182533

Health Authority: Canada: Health Canada