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Completed

NCT Number: NCT01263548

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.

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Key information

Conditions

Attention Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mood Disorders Psychopharmacology Unit

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lisdexamfetamine dimesylate

Drug

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

Other names: Vyvanse

Primary outcomes

  1. Metabolic parameters

    Time frame: Screening (Week -1) to Endpoint (Week 4); Completed weekly on all 6 visits

    Weight; BMI; Waist circumference

Secondary outcomes

  1. ADHD-RS

    Time frame: Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits

    Measure of ADHD symptoms

  2. CAARS

    Time frame: Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits

    Measure of ADHD symptoms

  3. CGI-BP

    Time frame: Baseline (Week 0) to Endpoint (Week 4); Completed weekly on all 6 visits

  4. Q-LES-Q

    Time frame: Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits

    Quality of Life

  5. AAQoL

    Time frame: Baseline (Week 0), Week 2, Endpoint (Week 4); Completed on 3 visits

    Quality of Life

  6. Metabolic Peptidergic systems

    Time frame: Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits

    Insulin; Resistin; Ghrelin; Leptin; Adiponectin

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Shire

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 20, 2010
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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