Clinical Trial: Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents

Brief 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 Summary:

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 scanni
Sponsor: University of Michigan

Current Primary Outcome: 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 ]

Original Primary Outcome: Clinical Global Impression (CGI) Scale [ Time Frame: Measured before treatment, at nine treatment study visits, and 12 weeks after starting treatment ]

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Measured before treatment, at nine treatment study visits, and 12 weeks after starting treatment ]

Information By: University of Michigan

Dates:
Date Received: July 9, 2010
Date Started: July 2010
Date Completion:
Last Updated: May 26, 2015
Last Verified: May 2015