Guanfacine Extended Release and Mindfulness Skills Therapy
Status:
Withdrawn
Trial end date:
2019-12-03
Target enrollment:
Participant gender:
Summary
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.