Summary:
The main purpose of this study is to learn how well the study drug works and how safe the study drug is. If you take part in this study, you will stop taking the anti-psychotic medication you are currently on and instead, receive either one of two doses of the study drug, or you may receive a placebo. A placebo looks like the study drug but does not contain any active drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing.
How long will my participation in this study last? You will be in this study for approximately 13 weeks, and you will be hospitalized during this time although you may be able to leave on supervised day passes after Week 3, if the study doctor thinks it is right for you. There are 3 phases or parts in this study. • The Screening Phase which can last up to 21 days before you start the study drug. • The Study Treatment Phase starts on Day 1 and lasts up to 45 days. You will take the study drug every day during the Study Treatment Phase. There will be study assessments on Days 1 and 4, and Weeks 1, 2, 3, 4, 5, and 6. If you leave the study early you will have an Early Termination study visit. • The Follow-up Phase starts at the end of the Study Treatment Phase and lasts for 4 weeks. There will be a phone call, or other means of communication, to check on your health at the end of the 4-week period.
Qualified Participants Must:
• Are between the ages of 18 to 65
• Have been diagnosed with schizophrenia by a doctor.
• Are experiencing an acute exacerbation or relapse of psychotic symptoms.
•Willing to discontinue all prohibited medications* prior to and during the trial period. *Medications will be reviewed with clinical research study staff during eligibility process.
•Reside in a stable living environment. BMI 18- 40 kg m2
Qualified Participants May Receive:
Compensation up to $10,000 and study drug and patient care provided at no cost to participants. During the inpatient portion of study, participants will be provided food as well.