Trial Outcomes & Findings for Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse (NCT NCT00573534)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

up to 24 weeks

Results posted on

2017-02-20

Participant Flow

Subjects were recruited from March 2008 until January 2010 from parents with adolescent children in adolescent substance use treatment center and with parents of children with ADHD whether there were older children who might have substance use problems. Community pediatricians and child psychiatrists supplemented this approach.

This was an open-label study, hence no group assignment. Thirteen families were offered study participation, 8 accepted. The five families that declined participation cited the impracticality of weekly visits and/or the adolescent's oppositional behavior as primary reasons for nonparticipation.

Participant milestones

Participant milestones
Measure	Group 1 Adolescents with ADHD and an older sibling with Substance Use Disorder
Overall Study STARTED	8
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Adolescents with ADHD and an older sibling with Substance Use Disorder
Overall Study oppositional behavior	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=8 Participants Adolescents with ADHD and an older sibling with substance use disorder
Age, Categorical <=18 years	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	14.2 years STANDARD_DEVIATION 2 • n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	7 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 24 weeks

Population: All patients who agreed to participate. Last Observation Carried Forward was used final outcome.

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

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants Lisdexamfetamine and family counseling
Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit much improved (70 percent or more drop in ADHD-RS)	6 participants 0
Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit unimproved	2 participants 0

SECONDARY outcome

Timeframe: up to 24 weeks

Population: The 8 subjects who took at least one dose of the medication and returned for follow up were included.

This outcome measure integrates data from self report supplied in the Time Line Follow Back (a self report summary of all substance and alcohol use over the previous week or month) with evidence from periodic (weekly to monthly) urine toxicologies.

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants Lisdexamfetamine and family counseling
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. intermittent	3 participants 0
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. none-low	5 participants 0

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephen J. Donovan MD

Columbia University/New York State Psychiatric Instittue

Phone: 646 774 8078

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place