| City: |
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Ann Arbor |
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State:
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MI |
| Zip Code: |
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48109 |
| Conditions: |
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Anxiety Disorders |
| Purpose: |
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This study will attempt to identify gene and brain activity markers that predict whether
people with social anxiety disorder will respond to selective serotonin reuptake inhibitor
medications.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
For social anxiety disorder group:
- 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:
- Clinically significant medical or neurologic condition
- 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
Additional exclusion criteria for the functional MRI studies:
- Left-handedness, as determined by standard questionnaire
- Presence of ferrous-containing metals within the body, such as aneurysm clips,
shrapnel, or retained particles
- Claustrophobia |
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| Study is available at: |
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University of Michigan
Ann Arbor, MI 48109
United States
Primary Contact:
K. Luan Phan, MD
Email: luan@med.umich.edu
Phone: 734-936-9275 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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