Phobia, Social | Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders
Phobia, Social research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Major Depressive Disorder
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Sertraline25 - 200 mg/day x 16 weeks
Drug:Placebo25 - 200 mg/day x 16 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 2002
Completed Date: January 2018
Phase: Phase 4
Primary Outcome: Clinical Global Impression - Improvement ≤ 2
Secondary Outcome: Mean change from baseline on the following scales: Quality of Life and Employment Satisfaction Questionnaire
Study sponsors, principal investigator, and references
Principal Investigator: Michael Van Ameringen, MD, FRCPC
Lead Sponsor: Hamilton Health Sciences Corporation