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
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
  Purpose

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.


Condition Intervention
Attention Deficit/Hyperactivity Disorder
Bipolar Disorder
Drug: lisdexamfetamine dimesylate

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 45
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Vyvanse

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Individuals who have a diagnosis of Bipolar Disorder and ADHD.

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 </= 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263548

Locations
Canada, Ontario
Mood Disorders Psychopharmacology Unit
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Shire
  More Information

Additional Information:
No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01263548     History of Changes
Other Study ID Numbers: Vyvanse-BD
Study First Received: December 14, 2010
Last Updated: May 31, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Bipolar Disorder
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014