Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse

NCT00573534 | Completed Phase 4 Results

• 1 other identifier: 5522
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; ADHD; ADD; Prevention; Substance use; Adolescent

Outcome Measures

Primary Outcomes (1)

• Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit

  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 parent and adolescent to achieve a consensus score, or a best estimate on the clinician's part when consensus could not be achieved

  up to 24 weeks

Secondary Outcomes (1)

• Number of Participants With Low or no Substance Use During the Study vs the Number With Intermittent Use Judged by (1)Time Line Follow Back (Confidential Clinician Administered Record of Recent Substance Use) (2) Urine Toxicology.

  up to 24 weeks

Study Arms (1)

Open Label Vyvanse

EXPERIMENTAL

Open Label Vyvanse (lisdexamphetamine) in doses of 30-70 mgs over 8 weeks in younger siblings of substance abusing older siblings with a history of treatment for ADHD

Drug: Vyvanse

Interventions

Vyvanse DRUG

Patients will be titrated from 30 mgs to 50 mgs to 70 mgs over four weeks, as tolerated and as needed to control ADHD symptoms

Also known as: Lisdexamphetamine is marketed as Vyvanse

Open Label Vyvanse

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Meets DSM-IV-TR criteria for ADHD
• Has a Gender-Matched older sibling with ADHD and substance dependence
• Medically healthy
• Parents give informed consent
• Child gives assent

You may not qualify if:

• History of cardiac abnormality, past cardiac problems or family history of the same, history of fainting, open-heart surgery, and arrhythmia
• History of paranoia on stimulant medication
• Seizure or other neurological disturbance
• Pregnancy
• Moderate to severe mental deficiency as determined by IQ \<60 or placement in special education for mental deficiency
• Physical exam or laboratory results with significant abnormalities
• Active suicidal or homicidal ideation or history of suicide attempts
• Unequivocal manic or hypomanic episode
• Sexually active females who are unwilling to use effective methods of contraception
• Psychosis or psychosis in a first degree relative
• Current Major Depression
• Individuals who have previously seen a cardiologist until reevaluated by a cardiologist
• Individuals for whom the current cardiac evaluation is not definitive until seen by a cardiologist and given an echocardiogram
• Individuals with Tic disorder
• Significant co-morbid anxiety disorders (i.e., OCD, Panic, PTSD)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Substance-Related Disorders

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Stephen J. Donovan MD
• Organization: Columbia University/New York State Psychiatric Instittue

sd45@columbia.edu

646 774 8078

Study Officials

• Stephen J Donovan, MD

  Columbia University / New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: March 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 20, 2017
• Results First Posted: November 29, 2011

Record last verified: 2016-12