Guanfacine Extended Release and Mindfulness Skills Therapy

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.

Conditions

• Stress Disorder

Interventions

DRUG

Guanfacine Extended Release

Intuniv (guanfacine) is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD) in children who are at least 6 years old. An open-label trail of guanfacine extended release (GXR 1-4 mg/daily; Intuniv™) suggested benefits in improving behavioral and emotional regulation in children and adolescents with symptoms of traumatic stress. However, to date no controlled clinical trial has been completed assessing the effects of GXR on traumatic stress symptoms in youths

BEHAVIORAL

Mindfulness Skills Therapy

Mindfulness is a therapy for anxiety and stress. Mindfulness forms of therapy involve regulation of attention, maintaining it in immediate experience, regardless of the valence and desirability of the experience. To reduce anxiety, Mindfulness encourages observing and accepting anxiety-related thoughts

DRUG

Placebo

Placebo oral capsule

Sponsors & Collaborators

• Shire

  collaborator INDUSTRY

• Yale University

  collaborator OTHER

• UConn Health

  lead OTHER

Principal Investigators

• Asima F Zehgeer, MD · UConn Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-01

Primary Completion

2019-12-03

Completion

2019-12-03

FDA Drug

Yes

Countries

• United States

Study Locations