Clinical Trial 40973

Oceanside, CA 92056


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

Qualified Participants May Receive:

Compensation and Transportation

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.