New clinical trial for adults with schizophrenia

Summary

• We are conducting a clinical trial to research a new investigational drug for people with schizophrenia. The drug is considered ‘investigational’ as it is not yet approved by any public health agency for any kind of treatment.
• The clinical trial will involve taking multiple capsules daily for up to 3 weeks.

• The trial will help us determine how safe and tolerable the drug is, how long the drug stays in the body, and how it affects the body

If you are interested in participating in the trial:

• You will need to attend a screening appointment so we can check if you are eligible to take part in the trial. At this appointment we will perform several assessments, including but not limited to taking blood samples, checking your heart and carrying out a physical examination.
• The trial will involve:
  
  • An inpatient stay of up to 14 days during the Screening Period (28-day period), where you will stop taking your usual antipsychotic medication (washout period) as advised by the Study Doctor.
  • A further 21-day in-house Treatment Period, during which you will receive daily oral doses of the investigational drug and undergo assessments to monitor how the drug works in your body and how safe and tolerable it is.
  • After your final dose, you will remain in the unit for at least 7 days for safety checks and to restart your usual schizophrenia medication. The Study Doctor will decide whether you can be discharged after 7 days or should stay longer. A final follow-up visit will take place 14 days after your last dose.
  • Overall, the study lasts about 9 weeks, with up to three study visits: your screening visit, the long in-house stay (up to 42 days and 41 nights), and the final follow-up visit if you have been discharged.