Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents
Condition: Social Phobia; Generalized Anxiety Disorder; Separation Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social; Anxiety, Separation
Study type: Observational

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).
    

Detailed description: 
      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.
    

Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with one or more of the following anxiety disorders (diagnosed by our study):
        Generalized Anxiety Disorder, Social Anxiety Disorder, Separation Anxiety Disorder.
      
Biospecimen description: 
      saliva
    
Keywords: Anxiety; Social Phobia; Social Anxiety; Generalized Anxiety; Separation Anxiety