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

Anxiety Disorders Clinical Trial

Official title:

Neuro-Genetic Markers of SSRI Treatment Response in Social Anxiety Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00872131
• Other study ID #: K23MH076198
• Secondary ID: K23MH076198DAHBR
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2009
• Last updated: November 21, 2011
• Start date: March 2008
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression (CGI) Scale		Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment	No
Secondary	Liebowitz Social Anxiety Scale (LSAS)		Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment	No