An observational study in Social Phobia, Generalized Anxiety Disorder and Separation Anxiety Disorder, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 7 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-27.
Sponsored by University of Michigan · Observational
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).
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.
367 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.
This study's enrollment of 156 is below the median of 250 across 20 observational studies indexed under Phobia, Social.
Browse Phobia, Social studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with one or more of the following anxiety disorders (diagnosed by our study): Generalized Anxiety Disorder, Social Anxiety Disorder, Separation Anxiety Disorder.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For anxiety disorder group:
For healthy control group:
Exclusion Criteria for all:
Additional exclusion criteria for the functional MRI studies:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with Generalized Anxiety Disorder, and/or Social Anxiety Disorder, and/or Separation Anxiety Disorder will undergo MRI scanning, EEG's, and sertraline treatment.
Drug: Sertraline
Healthy control participants will undergo MRI scanning and EEG's.
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).
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.
Also known as: Zoloft
Clinical Global Impression (CGI) Scale
Time frame: Change from Baseline in CGI score at 12 or 16 weeks after treatment SSRI or CBT, respectively). Measured before treatment, at each treatment study visits, and after treatment
Liebowitz Social Anxiety Scale (LSAS)
Time frame: Change from Baseline in LSAS score at 12 or 16 weeks after treatment SSRI or CBT, respectively). Measured before treatment, at each treatment study visits, and after treatment
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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