Identifying Brain and Genetic Markers of Sertraline Treatment Response in People With Social Anxiety Disorder
NCT ID: NCT00872131
Last Updated: 2011-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2008-03-31
2011-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Generalized social anxiety disorder participants
Participants with generalized social anxiety disorder will undergo MRI scanning and sertraline treatment.
Sertraline
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.
Healthy control participants
Healthy control participants will undergo MRI scanning.
No interventions assigned to this group
Interventions
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Sertraline
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current diagnosis of social anxiety disorder, generalized subtype
* Physically healthy, as confirmed by comprehensive medical history, physical exam, and laboratory testing
For healthy control group:
* Never been diagnosed with either Axis I or Axis II mental disorders
* Physically healthy, as confirmed by comprehensive medical history, physical exam, and laboratory testing
Exclusion Criteria
* Diagnosis of primary comorbid anxiety disorder, defined by which disorder is the more debilitating and clinically salient
* History of bipolar disorder or schizophrenia
* Presence of an organic mental syndrome, mental retardation, or pervasive developmental disorder
* Current major depressive disorder or major depression within the past 6 months
* Hamilton Rating Scale for Depression score greater than 18
* Alcohol or drug abuse or dependence within the past year
* Current suicidal ideation
* Diagnosis of an Axis II personality disorder, except for avoidant personality disorder
* Treatments with psychotropic or psychoactive medications within the 2 weeks before screening (or 8 weeks for fluoxetine and 4 weeks for monoamine oxidase inhibitors)
* Positive urine drug screen results
* Pregnancy
* Left-handedness, as determined by standard questionnaire
* Presence of ferrous-containing metals within the body, such as aneurysm clips, shrapnel, or retained particles
* Claustrophobia
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Michigan
OTHER
Responsible Party
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K. Luan Phan
Associate Professor
Principal Investigators
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K. Luan Phan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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