Vyvanse and Glucose Intolerance in Children With Attention Deficit Hyperactivity Disorder (ADHD) and Obesity

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01017263
• Collaborator: Shire (Industry)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 32
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study to assess the effects of chronic administration of Vyvanse (lis-dexamphetamine) on glucose metabolism in a sample of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who also have glucose intolerance and are obese.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder; Glucose Intolerance; Obesity	Drug: Lis-dexamphetamine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vyvanse and Glucose Intolerance in Children With ADHD and Obesity
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open label Vyvanse Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.	Drug: Lis-dexamphetamine; Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.; Other Names: Vyvanse, LDX

Outcome Measures

Primary Outcome Measures

1. Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial. [Baseline to end of study]

   The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• male or female, ages between 8 and 17

• Body Mass Index > 30

• fasting blood sugar between 90-100 mg/dl

• 2 hour post prandial >140 <180 mg/dl

• meets criteria for a diagnosis of ADHD, any subtype

Exclusion Criteria:

• known cardiovascular disease or diabetes

• structural cardiac abnormalities, abnormal ECGs, family history of sudden death

• positive urine drug screen

• fasting blood sugar level > 126 mg/dl

• HbA1c > 6.5 %

• Weight > 300 lbs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Child and Family Study Center	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University
• Shire

Investigators

• Principal Investigator: Scott H Kollins, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01017263
• Other Study ID Numbers: Pro00019063
• First Posted: Nov 20, 2009
• Last Update Posted: Feb 20, 2014
• Last Verified: Sep 1, 2013

• Keywords provided by Duke University: ADHD; Glucose Intolerance; Obesity; Vyvanse
• Additional relevant MeSH terms: Hyperkinesis; Obesity; Glucose Intolerance; Attention Deficit Disorder with Hyperactivity; Lisdexamfetamine Dimesylate; Dextroamphetamine

Study Results

Participant Flow

Recruitment Details	Potential participants are pre-screened at the Duke Obesity Clinic. Eligible participants then come to the Duke ADHD Clinic for their first study visit.
Pre-assignment Detail	At the screening visit, psychiatric evaluation and fasting labs were obtained to determine eligibility. Of the 14 subjects only 2 qualified and received study drug. Reasons for screen fails: 8-did not meet lab parameters for glucose intolerance, 1-elevated BP, 1- elevated TSH, 1- doing well with current ADHD treatment, 1- diagnosed with depression.

Arm/Group Title	Open Label Vyvanse
Arm/Group Description	Eligible subjects will be dispensed open label LDX (Vyvanse). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
Period Title: Overall Study
STARTED	14
COMPLETED	2
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Open Label Vyvanse
Arm/Group Description	All subjects receive Vyvanse.
Overall Participants	14
Age (Count of Participants)
<=18 years	14 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.92 (2.73)
Sex: Female, Male (Count of Participants)
Female	8 57.1%
Male	6 42.9%
Region of Enrollment (participants) [Number]
United States	14 100%

Outcome Measures

1. Primary Outcome

Title	Pre and Post Study Fasting Blood Sugar and Two Hour Post Prandial.
Description	The study was terminated due to lack of enrollment therefore outcome measures were not assessed. If completed, the expected outcomes would have shown an improvement of the subject's fasting and 2 hour post prandial glucose values, insulin levels and HbA1c. However, all of the subjects recruited did not have abnormal values to start with. The two subjects who were enrolled were the younger kids to which the entry lab criteria do not apply.
Time Frame	Baseline to end of study

Outcome Measure Data

Analysis Population Description

Study terminated early - no analysis performed on the single subject with data.

Arm/Group Title	Vyvanse Open Label
Arm/Group Description	Eligible subjects were dispensed open label LDX (VyvanseTM). All subjects started at 20 mg once a day dose and were titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level was allowed.
Measure Participants	0

Adverse Events

Arm/Group Title	Open Label Vyvanse
Arm/Group Description	Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
All Cause Mortality
	Open Label Vyvanse
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Open Label Vyvanse
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Open Label Vyvanse
	Affected / at Risk (%)	# Events
Total	0/14 (0%)

Limitations/Caveats

Study was terminated due to the high number of failures of lab criteria for glucose intolerance which is one of the entry criterion. No data were analyzed.

More Information

Certain Agreements

All Principal Investigators ARE 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.