To Evaluate the Safety and Metabolic Profile of Vyvanse f... | NCT01263548

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Dec 14, 2010

First Submission Date that Met QC Criteria

Dec 17, 2010

First Posted Date

Dec 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2012

Last Update Posted Date

Jun 1, 2012Estimated

Name	Class
Shire	INDUSTRY

Description Module

Brief Summary

ADHD in the adult population is associated with several measures of harmful dysfunction. For example, adult ADHD is associated with high rates of separation/divorce and never-married status, lower educational attainment and occupational achievement, absenteeism, presenteeism, and job termination, as well as decreased social function. Individuals with adult ADHD are more likely than controls to have a comorbid diagnosis of bipolar disorder, alcohol and substance abuse, as well as antisocial personality disorder.

Psychostimulants are the most frequently employed medications in the treatment of adult ADHD. Several psychostimulants are Health Canada and US FDA-approved for the treatment of ADHD symptoms in adulthood.

Hitherto, no trial has evaluated the safety and efficacy of a psychostimulant in the treatment of ADHD symptomatology in adult individuals with bipolar disorder.

Vyvanse is the first prodrug stimulant indicated for the treatment of adult (and pediatric) ADHD. Vyvanse is a therapeutically inactive molecule (i.e. prodrug). After oral ingestion, lisdexamfetamine is converted to l-lysine, a naturally occurring essential amino acid, and active d-amphetamine, which is responsible for the drug's activity. Vyvanse provides a longer duration of effect consistent throughout the day with reduced potential for risk of abuse. Vyvanse is generally well tolerated with an adverse event profile similar to other psychostimulant medications. Available evidence indicates that in most treated subjects, Vyvanse is weight-neutral and/or is associated with weight loss. Moreover, in some individuals, it is associated with improvement in both glucose and lipid homeostasis.

The evaluation of safety/tolerability profiles as well as the effectiveness of lisdexamfetamine in a "real-world" population has significant translational value.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vyvanse		This is an open-label study which means that all study participants will be taking active study medication, Vyvanse.	Drug: lisdexamfetamine dimesylate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lisdexamfetamine dimesylate	Drug	Dosage form: Capsules; Dosage strength: 30-70mg/day, flexible dosing; Duration: 4 weeks	Vyvanse

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metabolic parameters	Weight; BMI; Waist circumference	Screening (Week -1) to Endpoint (Week 4); Completed weekly on all 6 visits

Secondary Outcomes

Measure	Description	Time Frame
ADHD-RS	Measure of ADHD symptoms	Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits
CAARS	Measure of ADHD symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatient status
Male or female subjects between the ages of 18 to 55 years, inclusive
Primary diagnosis of Bipolar Disorder and ADHD according to criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) using the Mini International Neuropsychiatric Interview.
Agree to use reliable method of birth control
YMRS score \

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Individuals who have a diagnosis of Bipolar Disorder and ADHD.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mood Disorders Psychopharmacology Unit		Toronto	Ontario	M5T 2S8	Canada

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders

ID	Term
D003913	Dextroamphetamine
D000661	Amphetamine
D000662	Amphetamines
D010627	Phenethylamines
D005021	Ethylamines
D000588	Amines
D009930	Organic Chemicals