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SchizophreniaDecember 2023Summary reviewed May 2026

What the RISE Trial Found — Long-Acting Risperidone Injection for Schizophrenia

RISE tested TV-46000, a long-acting risperidone injection given monthly or every two months, against an inactive injection in 544 adults with schizophrenia. Both dosing schedules dramatically delayed relapse compared with the inactive injection.

What the trial was testing

The RISE enrolled 544 patients with schizophrenia. The study was sponsored by Teva Branded Pharmaceutical Products R&D and tracked outcomes across the full group of patients who matched the trial's eligibility profile.

It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.

What the results showed

Time to relapse stretched 5x longer with the monthly injection.

The Lancet Psychiatry · 2023 · NCT03503318

These findings — that time to relapse on monthly long-acting risperidone vs. inactive injection — were published in the The Lancet Psychiatry and represent the headline result of the study.

Researchers tracked outcomes across 544 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.

What this means for patients

For patients with schizophrenia, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.

What you can do now

Risperidone extended-release injection (Uzedy) was FDA-approved in 2023 and is available now. It is given as an under-the-skin injection by a healthcare provider every one or two months. Ask a psychiatrist about long-acting injectable options if pill adherence is a challenge.

Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.