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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
K. Luan Phan, University of Michigan
ClinicalTrials.gov Identifier:
NCT00872131
First received: March 30, 2009
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Anxiety Disorders
Drug: Sertraline
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neuro-Genetic Markers of SSRI Treatment Response in Social Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Clinical Global Impression (CGI) Scale [ Time Frame: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Measured before treatment, at five treatment study visits, and 12 weeks after starting treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Saliva samples


Enrollment: 200
Study Start Date: March 2008
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community and outpatient clinic samples

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872131

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: K. Luan Phan, MD University of Michigan
  More Information

No publications provided

Responsible Party: K. Luan Phan, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00872131     History of Changes
Other Study ID Numbers: K23 MH076198, K23MH076198, DAHBR 9A-ASPI, 5K23MH076198
Study First Received: March 30, 2009
Last Updated: November 21, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Anxiety
Social Phobia
Generalized Social Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Phobic Disorders
Mental Disorders
Pathologic Processes
Sertraline
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014