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Clinical Trial Details

Overview

Research Study Summary

A Phase 4 clinical study for patients using Sertraline and Placebo

Research Study Title

Sertraline in the Treatment of Generalized Social Phobia With Comorbidity

Purpose

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.

To Learn more
Phase

4

Gender

Both Male and Female

Age

18 to 70 Years

Overall Status

Recruiting

Lead Sponsor

Hamilton Health Sciences Corporation

Duration

150 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years to 70 Years

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

Site Locations (1)

Country State City Zip Facility and Contact
Canada Ontario Hamilton L8S 1B7 MacAnxiety Research Centre
Beth Patterson, BScN, BEd
905-921-7644
bpatter@mcmaster.ca

Michael Van Ameringen, MD, FRCPC
Principal Investigator

Catherine Mancini, MD, FRCPC
Sub-Investigator

Steve Collins, MBChB, FRCPC
Sub-Investigator

Contact

Beth Patterson, BScN, BEd
905-921-7644
E-mail:

NCT ID: NCT00182533

Date Last Changed: March 4, 2013

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