Status:
COMPLETED
Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Social Phobia
Generalized Anxiety Disorder
Eligibility:
All Genders
7-19 years
Brief Summary
This study will attempt to identify gene and brain activity markers that predict whether children and adolescents with anxiety disorders will respond to selective serotonin reuptake inhibitor medicati...
Detailed Description
Anxiety disorders are common and highly disabling conditions of children and adolescence that often do not remit, and increase the risk of depression, anxiety, substance abuse, and suicide in adulthoo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- For anxiety disorder group:
- 7-19 years of age
- Current diagnosis of social anxiety disorder, generalized anxiety disorder and/or separation anxiety disorder
- Physically healthy, as confirmed by comprehensive medical history, physical exam, and laboratory testing
- For healthy control group:
- 7-19 years of age
- 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 for all:
- Clinically significant medical or neurologic condition
- Life history of bipolar disorder, schizophrenia, mental retardation, or pervasive developmental disorder or current alcohol/drug abuse or dependence
- Severe current depression, as indicated by the Child Depression Inventory, or by the clinical decision of the rater or doctor
- Current suicidal ideation
- Treatment with psychotropic/psychoactive medications in the past two weeks (4 weeks for fluoxetine and monoamine oxidase inhibitors) before screening
- Positive urine drug screen results
- Pregnancy
- Clinically significant medical condition that interferes with metabolism of sertraline
- Multiple drug allergies
- Prior failure of response to sertraline for anxiety, as defined by adequate duration to achieve a clinical response
- Refusing to attend school because of anxiety
- Additional exclusion criteria for the functional MRI studies:
- Presence of ferrous-containing metals within the body, such as aneurysm clips, shrapnel, or retained particles
- Claustrophobia
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01160588
Start Date
July 1 2010
End Date
March 1 2015
Last Update
May 27 2015
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109