Status:
COMPLETED
To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Shire
Conditions:
Attention Deficit/Hyperactivity Disorder
Bipolar Disorder
Eligibility:
All Genders
18-55 years
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 edu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01263548
Start Date
October 1 2010
End Date
January 1 2012
Last Update
June 1 2012
Active Locations (1)
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1
Mood Disorders Psychopharmacology Unit
Toronto, Ontario, Canada, M5T 2S8