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| Sponsor: | University of Michigan |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by (Responsible Party): | K. Luan Phan, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01160588 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
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Social Phobia Generalized Anxiety Disorder Separation Anxiety Disorder |
Drug: Sertraline |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents |
saliva
| Estimated Enrollment: | 240 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
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Sertraline treatment
Participants with Generalized Anxiety Disorder, and/or Social Anxiety Disorder, and/or Separation Anxiety Disorder will undergo MRI scanning, EEG's, and sertraline treatment.
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Drug: Sertraline
Oral sertraline will be started at 25 mg/day, increasing on subsequent visits to 50, 75, 100, 125, 150, and 200mg/day) Unless adverse effects become problematic, the goal is for subjects to reach 200mg/day. Dosing of sertraline is flexible, based on tolerance (absence of side effects) and clinical response.
Other Name: Zoloft
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Healthy Controls
Healthy control participants will undergo MRI scanning and EEG's.
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Cognitive Behavioral Therapy
Participants with Generalized Anxiety Disorder, and/or Social Anxiety Disorder, and/or Separation Anxiety Disorder will undergo MRI scanning, EEG's, and talk therapy (CBT).
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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.
This study will examine variations in genetics and brain reactivity among children and adolescents who do and do not respond to SSRIs and Cognitive Behavioral Therapy. Through this, the study will identify neurological and genetic biomarkers that can predict responsiveness to SSRI/CBT treatment in those with anxiety disorders.
For SSRI/medication treatment arm:
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.
Participation in this study will last approximately 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. In addition, participants will complete tasks while connected to an Electroencephalography(EEG) machine before and after the 12 weeks of treatment, and will have the option of additional EEG's at weeks 2, 4, and 8.
For CBT arm:
Participation in this study will last 16 weeks. All participants will complete similar study visits at entry, within 2 weeks of entry, and approximately 16 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 approximately 16 weeks, will involve MRI scans and behavioral tasks to be conducted inside and outside the MRI scanner. Over the 16 weeks between MRI scanning sessions, participants with anxiety disorders will participate in type of talk therapy--Cognitive Behavioral Therapy--on a weekly basis. In addition, participants will complete tasks while connected to an Electroencephalography(EEG)machine before and after the 16 weeks of treatment, and will have the option of additional EEG's at weeks 2, 4, and 8.
Eligibility| Ages Eligible for Study: | 7 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Participants with one or more of the following anxiety disorders (diagnosed by our study): Generalized Anxiety Disorder, Social Anxiety Disorder, Separation Anxiety Disorder.
Inclusion Criteria:
For anxiety disorder group:
For healthy control group:
Exclusion Criteria for all:
Additional exclusion criteria for the functional MRI studies:
Contacts and Locations| Contact: Kelly Kreger, M.S.W. | 734-763-3134 | kkreger@med.umich.edu |
| Contact: K. Luan Phan, M.D. | 734-936-9275 | luan@med.umich.edu |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: K. Luan Phan, M.D. | |
| Principal Investigator: | K. Luan Phan, M.D. | University of Michigan |
More Information
| Responsible Party: | K. Luan Phan, Principal Investigator; Associate Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01160588 History of Changes |
| Other Study ID Numbers: | R01MH086517, R01MH086517 |
| Study First Received: | July 9, 2010 |
| Last Updated: | November 23, 2011 |
| Health Authority: | United States: Federal Government |
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Anxiety Social Phobia Social Anxiety Generalized Anxiety Separation Anxiety |
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Anxiety Disorders Anxiety, Separation Mental Disorders Phobic Disorders Mental Disorders Diagnosed in Childhood Sertraline Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |