Stress Disorder Clinical Trial
Official title:
Guanfacine Extended Release and Mindfulness in Traumatically Stressed Children and Adolescents Study
Teenagers are invited to take part voluntarily in a research study of a study drug known as guanfacine extended release (Intuniv™) and a type of psychotherapy called Mindfulness Skills Training which teaches people how to focus on the present moment in a nonjudgmental manner to help them cope with their stresses and worries. Teenagers are being asked to take part in this study if they have had traumatic stress related over arousal symptoms. He/she may also have difficulties with worries, anxiety, temper, aggression, quick mood changes, behavior problems, and/or difficulties with symptoms of Attention Deficit Hyperactivity Disorder (ADHD) including inattention, hyperactivity, and impulsivity with or without Posttraumatic Stress Disorder (PTSD); and is not responding adequately to his/her current treatment. The primary purpose of the teenager's participation in this study is to help answer the following research question(s), and not to provide treatment for his or her condition: - To investigate if Intuniv™ helps for the symptoms of traumatic stress and emotional and behavioral overarousal in children with a history of traumatic developmental stress with and without PTSD. - To investigate if Intuniv™ helps your teenager engage with and benefit from Mindfulness Skills Training therapy - To better understand how Intuniv™ works in the brain. - To investigate how well your child tolerates Intuniv™ during the study.
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