To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder

This study has been completed.

Sponsor:

Collaborator:

Shire Development LLC

Information provided by (Responsible Party):

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT01263548

First received: December 14, 2010

Last updated: May 31, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 14, 2010
Last Updated Date	May 31, 2012
Start Date ^ICMJE	October 2010
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 17, 2010)	Metabolic parameters [ Time Frame: Screening (Week -1) to Endpoint (Week 4); Completed weekly on all 6 visits ] [ Designated as safety issue: No ] Weight; BMI; Waist circumference
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01263548 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 17, 2010)	ADHD-RS [ Time Frame: Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits ] [ Designated as safety issue: No ] Measure of ADHD symptoms CAARS [ Time Frame: Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits ] [ Designated as safety issue: No ] Measure of ADHD symptoms CGI-BP [ Time Frame: Baseline (Week 0) to Endpoint (Week 4); Completed weekly on all 6 visits ] [ Designated as safety issue: Yes ] Q-LES-Q [ Time Frame: Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits ] [ Designated as safety issue: No ] Quality of Life AAQoL [ Time Frame: Baseline (Week 0), Week 2, Endpoint (Week 4); Completed on 3 visits ] [ Designated as safety issue: No ] Quality of Life Metabolic Peptidergic systems [ Time Frame: Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits ] [ Designated as safety issue: No ] Insulin; Resistin; Ghrelin; Leptin; Adiponectin
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder
Official Title ^ICMJE	Not Provided
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
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Individuals who have a diagnosis of Bipolar Disorder and ADHD.
Condition ^ICMJE	Attention Deficit/Hyperactivity Disorder Bipolar Disorder
Intervention ^ICMJE	Drug: lisdexamfetamine dimesylate Dosage form: Capsules; Dosage strength: 30-70mg/day, flexible dosing; Duration: 4 weeks Other Name: Vyvanse
Study Group/Cohort (s)	Vyvanse This is an open-label study which means that all study participants will be taking active study medication, Vyvanse. Intervention: Drug: lisdexamfetamine dimesylate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	45
Completion Date	January 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 </= 12 CGI-BP < 6 Able and willing to provide a written informed consent Exclusion Criteria: Current Axis I primary psychiatric diagnosis other than Bipolar Disorder and ADHD Current Axis II psychiatric disorder of primary clinical focus Active alcohol as well as illicit or other substance abuse during the past 3 months Current clinically unstable medical condition. Inability to understand and engage in the process of informed consent. Inability to cooperate with study procedures. Presence of known allergies or hypersensitivity to lisdexamfetamine History of destabilization when exposed to psychostimulant medication Current high risk of suicide Current treatment with corticosteroids Electroconvulsive therapy in the last 1 year Current participation in a separate clinical research study involving an investigational drug
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01263548
Other Study ID Numbers ^ICMJE	Vyvanse-BD
Has Data Monitoring Committee	Not Provided
Responsible Party	University Health Network, Toronto
Study Sponsor ^ICMJE	University Health Network, Toronto
Collaborators ^ICMJE	Shire Development LLC
Investigators ^ICMJE	Not Provided
Information Provided By	University Health Network, Toronto
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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