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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01263548
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : June 1, 2012
Information provided by (Responsible Party):
University Health Network, Toronto

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.

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

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Study Type : Observational
Actual Enrollment : 45 participants
Time Perspective: Prospective
Study Start Date : October 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Metabolic parameters [ Time Frame: Screening (Week -1) to Endpoint (Week 4); Completed weekly on all 6 visits ]
    Weight; BMI; Waist circumference

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals who have a diagnosis of Bipolar Disorder and ADHD.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01263548

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

Additional Information:
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Responsible Party: University Health Network, Toronto Identifier: NCT01263548     History of Changes
Other Study ID Numbers: Vyvanse-BD
First Posted: December 20, 2010    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Bipolar Disorder
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents