Key Study Points
· 12-week treatment phase (three arms: placebo, .15mg BID, .5mg BID)
· Duration of study is 19 weeks w/ 9 bi-weekly visits including follow-up
· Screening 6 hours + (can be split across 3 working days in 35-day window)
· Compensation is $107 including transportation (informant stipend $107)
· Informant necessary (greater than 4 hours a week) for participation and must be in person for screening but does not have to have interview on same day
· Uses AI cure app on personal cell phone for dosing accountability
· One-week placebo lead-in before randomization must be 80% compliant
· Teleconference interview in office during screening part 2
· Maximum of 40 cigarettes in a day
· Prohibited from alcohol consumption during study
· Native English speakers with stable living conditions
· be 18 to 50 w/ a schizophrenia diagnosis for at least 2 years
· have a BMI 17.5 to 40.5
· be symptomatically stable for at least 2 months (no hospitalizations)
· be on atypical antipsychotic
· have NO history/ known risk of seizures
· have NO more than 2 background antipsychotics
· have NO bypass surgery 6 months before screening
· use NO marijuana whether prescribed or recreational
· have NO current Hep B or C infection (cannot be positive for antibodies)
· have NO history of major alcohol consumption (women: 7 drinks/week men: 14 drinks/week)
· have NO suicide attempt in past 5 years
· have an Informant that must be present at screening but not for other assessment visits