Identifying Brain and Genetic Markers of Sertraline Treatment Response in People With Social Anxiety Disorder
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|ClinicalTrials.gov Identifier: NCT00872131|
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : November 23, 2011
|Condition or disease||Intervention/treatment|
|Anxiety Disorders||Drug: Sertraline|
Social anxiety disorder (SAD) is an anxiety disorder characterized by excessive fear and avoidance of social situations. Selective serotonin reuptake inhibitors (SSRIs) are a medication commonly prescribed to treat social anxiety disorder, but as many as 50% of people with SAD do not respond to SSRIs. Current theory suggests that neurological functioning and genetics may influence a patient's response to treatment. This study will examine variations in genetics and brain reactivity among people with SAD who do and do not respond to SSRIs. Through this, the study will identify neurological and genetic biomarkers that can predict responsiveness to SSRI treatment in people with SAD.
Participation in this study will last 14 weeks. Both healthy people and people with SAD will be recruited to participate. All participants will complete similar study visits at entry, within 2 weeks of entry, and 12 weeks after that. The first visit, which will occur at study entry, will include screening questionnaires, an interview with research staff, a medical screening, a urine test, and collection of saliva samples for genotyping. The second visit and the last visit, which will be separated by 12 weeks, will involve MRI scans and behavioral tasks to be conducted inside and outside the MRI scanner. Over the 12 weeks between MRI scanning sessions, participants with SAD will take sertraline, a common SSRI, on a daily basis. They will also attend five additional visits during this time to complete assessments of their symptoms. These visits will occur 1, 2, 4, 8, and 12 weeks after starting sertraline treatment. Participants with SAD will therefore be completing a symptom assessment, MRI scans, and behavioral tasks all on the final visit, 12 weeks after the second visit.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Observational Model:||Case Control|
|Official Title:||Neuro-Genetic Markers of SSRI Treatment Response in Social Anxiety Disorder|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||August 2011|
Generalized social anxiety disorder participants
Participants with generalized social anxiety disorder will undergo MRI scanning and sertraline treatment.
Oral sertraline will begin at 50 mg per day, then increase to 75 mg per day on Day 8, then increase to 100 mg per day on Day 15. The dose may be increased to 150 mg per day on Week 8, based on clinical response and medication toleration.
Other Name: Zoloft
Healthy control participants
Healthy control participants will undergo MRI scanning.
- Clinical Global Impression (CGI) Scale [ Time Frame: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment ]
- Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872131
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||K. Luan Phan, MD||University of Michigan|