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

Bipolar Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263548
• Other study ID #: Vyvanse-BD
• Status: Completed
• Phase: N/A
• First received: December 14, 2010
• Last updated: May 31, 2012
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: May 2012
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Bipolar Disorder
• Disease

Intervention

Drug:
• lisdexamfetamine dimesylate
Dosage form: Capsules; Dosage strength: 30-70mg/day, flexible dosing; Duration: 4 weeks

Locations

Country	Name	City	State
Canada	Mood Disorders Psychopharmacology Unit	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Shire

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic parameters	Weight; BMI; Waist circumference	Screening (Week -1) to Endpoint (Week 4); Completed weekly on all 6 visits	No
Secondary	ADHD-RS	Measure of ADHD symptoms	Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits	No
Secondary	CAARS	Measure of ADHD symptoms	Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits	No
Secondary	CGI-BP		Baseline (Week 0) to Endpoint (Week 4); Completed weekly on all 6 visits	Yes
Secondary	Q-LES-Q	Quality of Life	Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits	No
Secondary	AAQoL	Quality of Life	Baseline (Week 0), Week 2, Endpoint (Week 4); Completed on 3 visits	No
Secondary	Metabolic Peptidergic systems	Insulin; Resistin; Ghrelin; Leptin; Adiponectin	Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits	No

External Links

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