| City: |
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Ann Arbor |
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State:
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MI |
| Zip Code: |
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48109 |
| Conditions: |
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Social Phobia - Generalized Anxiety Disorder - Separation Anxiety Disorder |
| Purpose: |
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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.
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| Study summary: |
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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 adulthood. Available treatments are only modestly successful. When they are
effective, however, early treatment of anxiety disorders can reduce subsequent morbidity.
Although selective serotonin reuptake inhibitors (SSRI) are medications widely prescribed
for children and adolescents with anxiety disorders, little is known about the
neurobiological factors that predict which patients respond to treatment. 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
children and adolescents 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 those with anxiety disorders.
Participation in this study will last 14 weeks. Both healthy participants and participants
with anxiety disorders 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, 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 anxiety disorders will take
sertraline, a common SSRI, on a daily basis. They will also attend nine additional visits
during this time to complete assessments of their symptoms. These visits will occur 0, 1, 2,
3, 4, 6, 8, 10 and 12 weeks after the first scan. Participants with anxiety disorders will
therefore be completing a symptom assessment, MRI scans, and behavioral tasks all on the
final visit, 12 weeks after the second visit. |
| Criteria: |
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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 |
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| Study is available at: |
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University of Michigan
Ann Arbor, MI 48109
United States
Primary Contact:
Kelly Kreger, M.S.W.
Email: kkreger@med.umich.edu
Phone: 734-763-3134 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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