Current and Upcoming Binge Eating Disorder Studies
BED Study: Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of an investigational drug in Adults with BED
Mechanism: wakefulness promoting agen
Age: 18 - 55
BMI: >18, < 50
BED Duration: At least 2 days per week for at least 6 months
Cannabis: +UDS allowed at screen if not a habitual or chronic user & will discontinue use. Can redo UDS at least 4 weeks after initial UDS (must be negative).
Therapy: Okay if stable for at least 3 months prior to
Mechanism: wakefulness promoting agen
Age: 18 - 55
BMI: >18, < 50
BED Duration: At least 2 days per week for at least 6 months
Cannabis: +UDS allowed at screen if not a habitual or chronic user & will discontinue use. Can redo UDS at least 4 weeks after initial UDS (must be negative).
Therapy: Okay if stable for at least 3 months prior to screening
Exclusionary Diagnoses:
No lifetime history of bulimia or anorexia, any psychotic disorder, bipolar disorder, borderline, narcissistic or antisocial personality disorder, PTSD, OCD, tic disorder, or hospitalizations for psychiatric purposes
No history of seizures if not childhood febrile seizures, unexplained syncope, encephalopathy, HIV, history of any severe drug allergy, or LOC due to head trauma of > 5 minutes
No 1st degree relatives with schizophrenia, schizoaffective disorder, or bipolar disorder and no family history of Tourette’s
No MDD within 3 months
Additional Exclusion Criteria: No history of use of solriamfetol (Sunosi), Vyvanse, dasotraline, or any medications for BED, other eating disorders, or weight gain within 3 months of screening. No history of bariatric surgery.
Study Duration: 18 weeks
Payment: Clinic visits: $100 - 150, remote: $50, Up to $1,250 if all visits are completed
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