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| Tracking Information | |||||
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| First Received Date ICMJE | September 14, 2005 | ||||
| Last Updated Date | September 17, 2009 | ||||
| Start Date ICMJE | July 2002 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00182533 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders | ||||
| Official Title ICMJE | Sertraline in the Treatment of Generalized Social Phobia With Comorbidity | ||||
| 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 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. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 170 | ||||
| Estimated Completion Date | September 2009 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00182533 | ||||
| Responsible Party | Dr. Michael Van Ameringen, Anxiety Disorder Clinic, McMaster University Medical Centre | ||||
| Study ID Numbers ICMJE | 02-195 | ||||
| Study Sponsor ICMJE | McMaster University | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| Information Provided By | McMaster University | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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