Identifying Brain and Genetic Markers of Sertraline Treatment Response in People With Social Anxiety Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00872131

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 IV

MedlinePlus related topics: Anxiety

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Neuro-Genetic Markers of SSRI Treatment Response in Social Anxiety Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:	80
Study Start Date:	March 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: No Intervention 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

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

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

Locations

United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: K. Luan Phan, MD 734-936-9275 luan@med.umich.edu
Principal Investigator: K. Luan Phan, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

K. Luan Phan, MD

University of Michigan

More Information

No publications provided

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

Keywords provided by National Institute of Mental Health (NIMH):

Anxiety
Social Phobia
Generalized Social Anxiety Disorder

Study placed in the following topic categories:

Neurotransmitter Agents
Anxiety Disorders
Mental Disorders
Psychotropic Drugs
Sertraline

Phobic Disorders
Serotonin Uptake Inhibitors
Serotonin
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Phobic Disorders
Serotonin Uptake Inhibitors
Pharmacologic Actions

Serotonin Agents
Pathologic Processes
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Sertraline
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009