Overview

Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
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 medications or Cognitive Behavioral Therapy (CBT).
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Michigan
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Sertraline
Criteria
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