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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872131
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : November 23, 2011
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
K. Luan Phan, University of Michigan

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.

Condition or disease Intervention/treatment
Anxiety Disorders Drug: Sertraline

Detailed 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.

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neuro-Genetic Markers of SSRI Treatment Response in Social Anxiety Disorder
Study Start Date : March 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Generalized social anxiety disorder participants
Participants with generalized social anxiety disorder will undergo MRI scanning and sertraline treatment.
Drug: 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 Name: Zoloft

Healthy control participants
Healthy control participants will undergo MRI scanning.

Primary Outcome Measures :
  1. Clinical Global Impression (CGI) Scale [ Time Frame: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment ]

Secondary Outcome Measures :
  1. Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment ]

Biospecimen Retention:   Samples With DNA
Saliva samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community and outpatient clinic samples

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00872131

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Principal Investigator: K. Luan Phan, MD University of Michigan

Responsible Party: K. Luan Phan, Associate Professor, University of Michigan Identifier: NCT00872131     History of Changes
Other Study ID Numbers: K23MH076198 ( U.S. NIH Grant/Contract )
K23MH076198 ( U.S. NIH Grant/Contract )
5K23MH076198 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011

Keywords provided by K. Luan Phan, University of Michigan:
Social Phobia
Generalized Social Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs