Lead Sponsor

University Health Network, Toronto

Collaborators

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

No

•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

•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

Related studies

NCT07589647 · Bipolar Disorder (BD)

NCT06226025 · Bipolar Disorder, Delayed Sleep-Wake Phase Disorder

NCT07140913 · Mania, Bipolar Disorder

NCT06920940 · Bipolar Disorder (BD), Bipolar Disorder NOS, and more

NCT07172516 · Bipolar Disorder, Bipolar Depression, and more

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