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Trial record 29 of 110 for:    nrp 104 OR lisdexamfetamine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00573534
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : November 29, 2011
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: Vyvanse
Enrollment 8
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Group 1
Hide Arm/Group Description Adolescents with ADHD and an older sibling with Substance Use Disorder
Period Title: Overall Study
Started 8
Completed 5
Not Completed 3
Reason Not Completed
oppositional behavior             3
Arm/Group Title Group 1
Hide Arm/Group Description Adolescents with ADHD and an older sibling with substance use disorder
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
8
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
14.2  (2)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit
Hide Description 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
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who agreed to participate. Last Observation Carried Forward was used final outcome.
Arm/Group Title Group 1
Hide Arm/Group Description:
Lisdexamfetamine and family counseling
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
much improved (70 percent or more drop in ADHD-RS) 6
unimproved 2
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The 8 subjects who took at least one dose of the medication and returned for follow up were included.
Arm/Group Title Lisdexamfetamine Plus Family Therapy
Hide Arm/Group Description:
patients received lisdexamfetamine up to 70 mgs plus family counseling
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
none-low 5
intermittent 3
Time Frame Adverse events data were collected over 20 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description Intervention with Vyvanse
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen J. Donovan MD
Organization: Columbia University/New York State Psychiatric Instittue
Phone: 646 774 8078
EMail: sd45@columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00573534     History of Changes
Other Study ID Numbers: 5522
First Submitted: December 12, 2007
First Posted: December 14, 2007
Results First Submitted: August 15, 2011
Results First Posted: November 29, 2011
Last Update Posted: February 20, 2017