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Sponsors and Collaborators: |
Hamilton Health Sciences Pfizer |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00182533 |
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.
Condition | Intervention | Phase |
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Phobia, Social Panic Disorder Agoraphobia Obsessive-Compulsive Disorder Anxiety Disorders Major Depressive Disorder |
Drug: Sertraline Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Sertraline in the Treatment of Generalized Social Phobia With Comorbidity |
Estimated Enrollment: | 170 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Sertraline
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Drug: Sertraline
25 - 200 mg/day x 16 weeks
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2: Placebo Comparator
Placebo
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Drug: Placebo
25 - 200 mg/day x 16 weeks
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Beth Patterson, BScN, BEd | 905-521-2100 ext 76181 | beth@macanxiety.com |
Canada, Ontario | |
McMaster University Medical Centre | Recruiting |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Contact: Diedre L Henne, CA 905-521-2100 ext 74595 henne@hhsc.ca | |
Principal Investigator: Michael Van Ameringen, MD, FRCPC | |
Sub-Investigator: Catherine Mancini, MD, FRCPC | |
Sub-Investigator: Steve Collins, MBChB, FRCPC | |
Sub-Investigator: Jonathan Oakman, PhD | |
Sub-Investigator: Beth Patterson, BScN, BEd |
Principal Investigator: | Michael Van Ameringen, MD, FRCPC | Hamilton Health Sciences |
Responsible Party: | Anxiety Disorder Clinic, McMaster University Medical Centre ( Dr. Michael Van Ameringen ) |
Study ID Numbers: | 02-195 |
Study First Received: | September 14, 2005 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00182533 |
Health Authority: | Canada: Health Canada |
Generalized social phobia Comorbid panic disorder with agoraphobia Comorbid obsessive compulsive disorder Comorbid generalized anxiety disorder Comorbid major depressive disorder/Dysthymia |
Depression Agoraphobia Depressive Disorder, Major Depressive Disorder Phobic Disorders Serotonin Behavioral Symptoms |
Panic Disorder Anxiety Disorders Mental Disorders Mood Disorders Sertraline Dysthymic Disorder Obsessive-Compulsive Disorder |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Central Nervous System Agents Antidepressive Agents |