This study is testing a drug called NaBen® as an add-on treatment for adults with refractory schizophrenia (schizophrenia that hasn't responded well to other treatments). Participants will also be taking clozapine. The study aims to see if NaBen®, at doses of 1000 mg/day or 2000 mg/day, can improve remaining symptoms compared to a placebo (an inactive substance). Researchers will measure changes in your symptoms using a scale called PANSS (Positive and Negative Syndrome Scale) after 8 weeks of treatment. This study has received a "Breakthrough Therapy Designation" from the FDA, which means it may offer a significant improvement over available therapies.

Study design

This is a Phase II/III study, meaning it's testing both the best dose and how well the treatment works. It's double-blind (neither you nor your doctor will know if you're getting NaBen® or placebo) and randomized (you'll be assigned to a group by chance). About 287 participants are planned.

What's involved

If you join, you'll go through a screening process. If eligible, you'll receive either NaBen® or a placebo twice daily for 8 weeks. The study does not specify the number of visits or other procedures.

Compensation

Not stated in the trial record.

Follow-up

Your symptoms will be assessed at 8 weeks after starting the randomized treatment. The record does not specify follow-up beyond this point.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.