NCT00573534

Pilot Study of Vyvanse™ (Lisdexamfetamine Dimesylate) in Adolescents (Ages 11-15) With ADHD and an Older Sibling With ADHD and Substance Dependence

Completed Phase 4 Results posted Last updated 3 January 2017

What this trial tests

Phase 4 trial testing Vyvanse in Attention Deficit Hyperactivity Disorder in 8 participants. Completed in 1 March 2010.

Timeline

1 March 2008

Primary endpoint
1 January 2010

1 March 2010

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	1 March 2008
Primary completion	1 January 2010
Estimated completion	1 March 2010

Drugs / interventions tested

• Vyvanse (LISDEXAMFETAMINE) — full drug profile →

Conditions studied

• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 11 to 15, any sex, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit
  Time frame: up to 24 weeks
  The outcome is the number of subjects who achieved a clinically meaningful reduction in ADHD symptoms. This is defined as a 70% reduction from baseline as measured by change in the ADHD Rating Scale (ADHD-RS). The ADHD RS quantifies symptoms on a 0-3 scale, 0 meaning never present, 1 sometimes, 2 often present, 3 very often present. For this study, the scale was clinician administered using both p

Sponsor's own description

This is an open label pilot study to obtain information on the best way to study young adolescents with Attention Deficit Hyperactivity Disorder (ADHD)who may also be at risk of developing substance abuse, in part because of their ADHD. The plan is to recruit older children/young adolescents (age 11-15) who have ADHD and also have an older sibling with substance abuse. The treatment for ADHD in the 11-15 year old will be Vyvanse, a novel preparation of dextroamphetamine in which the molecule is inactivated and only becomes activated when it is digested. This preparation is felt to be safer from diversion while at the same time providing treatment for the younger siblings in which a bad outcome has already occurred in the family, namely the older sibling's substance abuse. As mentioned, this is an open-label study, a feasibility study to see if we can use this approach to study and treat high risk youth before they develop substance abuse.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Converging vulnerability factors for compulsive food and drug use.
   Serafine KM, O'Dell LE, Zorrilla EP. · · 2021 · cited 17× · PMID 33862029 · DOI 10.1016/j.neuropharm.2021.108556