Identifying Brain and Genetic Markers of Sertraline Treatment Response in People With Social Anxiety Disorder
Neuro-Genetic Markers of SSRI Treatment Response in Social Anxiety Disorder
3 other identifiers
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 30, 2009
CompletedFirst Posted
Study publicly available on registry
March 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedNovember 23, 2011
November 1, 2011
3.2 years
March 30, 2009
November 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Global Impression (CGI) Scale
Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment
Secondary Outcomes (1)
Liebowitz Social Anxiety Scale (LSAS)
Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment
Study Arms (2)
Generalized social anxiety disorder participants
Participants with generalized social anxiety disorder will undergo MRI scanning and sertraline treatment.
Healthy control participants
Healthy control participants will undergo MRI scanning.
Interventions
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.
Eligibility Criteria
Community and outpatient clinic samples
You may qualify if:
- 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
You may not qualify if:
- 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
- Left-handedness, as determined by standard questionnaire
- Presence of ferrous-containing metals within the body, such as aneurysm clips, shrapnel, or retained particles
- Claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Biospecimen
Saliva samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
K. Luan Phan, MD
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 30, 2009
First Posted
March 31, 2009
Study Start
March 1, 2008
Primary Completion
May 1, 2011
Study Completion
August 1, 2011
Last Updated
November 23, 2011
Record last verified: 2011-11