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

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder; Attention Deficit/Hyperactivity Disorder
• Intervention / Treatment: Drug: lisdexamfetamine dimesylate

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Mood Disorders Psychopharmacology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Individuals who have a diagnosis of Bipolar Disorder and ADHD.

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vyvanse; This is an open-label study which means that all study participants will be taking active study medication, Vyvanse.	Drug: lisdexamfetamine dimesylate; Dosage form: Capsules; Dosage strength: 30-70mg/day, flexible dosing; Duration: 4 weeks; Other Names: Vyvanse

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits
CGI-BP		Baseline (Week 0) to Endpoint (Week 4); Completed weekly on all 6 visits
Q-LES-Q	Quality of Life	Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits
AAQoL	Quality of Life	Baseline (Week 0), Week 2, Endpoint (Week 4); Completed on 3 visits
Metabolic Peptidergic systems	Insulin; Resistin; Ghrelin; Leptin; Adiponectin	Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Shire

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 17, 2010
• First Posted (Estimate): December 20, 2010

Study Record Updates

• Last Update Posted (Estimate): June 1, 2012
• Last Update Submitted That Met QC Criteria: May 31, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: Vyvanse-BD