Identifying Brain and Genetic Markers of Sertraline Treatment Response in People With Social Anxiety Disorder

University of Michigan

Status

Completed

Conditions

Anxiety Disorders

Treatments

Drug: Sertraline

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT00872131

K23MH076198 (U.S. NIH Grant/Contract)

5K23MH076198 (U.S. NIH Grant/Contract)

DAHBR 9A-ASPI

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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