Neuro-Genetic Markers of SSRI Treatment Response in Social Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical Global Impression (CGI) Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Generalized social anxiety disorder participants
Participants with generalized social anxiety disorder will undergo MRI scanning and sertraline treatment.
干预措施: Sertraline (Drug)
结局指标
主要结局
Clinical Global Impression (CGI) Scale
时间窗: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment
次要结局
- Liebowitz Social Anxiety Scale (LSAS)(Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment)
研究者
K. Luan Phan
Associate Professor
University of Michigan
