Status:
TERMINATED
Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Pfizer
Conditions:
Phobia, Social
Panic Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00182533
Start Date
July 1 2002
End Date
January 1 2018
Last Update
March 22 2018
Active Locations (1)
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1
MacAnxiety Research Centre
Hamilton, Ontario, Canada, L8S 1B7