Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03258476
Status:
WITHDRAWN
Last Update Posted:
2021-03-08
First Post:
2017-05-24
Brief Title:
Guanfacine Extended Release and Mindfulness Skills Therapy
Sponsor:
UConn Health
Organization:
UConn Health
Study Overview
Official Title:
Guanfacine Extended Release and Mindfulness in Traumatically Stressed Children and Adolescents Study
Status:
WITHDRAWN
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Contract terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Heshe may also have difficulties with worries anxiety temper aggression quick mood changes behavior problems andor 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 hisher current treatment
The primary purpose of the teenagers participation in this study is to help answer the following research questions 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
The primary purpose of the teenagers participation in this study is to help answer the following research questions 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None