Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents
Completed
Conditions studied: Social Phobia, Generalized Anxiety Disorder, Separation Anxiety Disorder
In brief
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).
Key facts
- Study ID
- NCT01160588
- Run by
- University of Michigan
- People needed
- 156
- Starts
- 2010-07-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-05-27
Who can join
Age: 7 and older, up to 19. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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