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.
Open schizophrenia trials
Accelerated Neuromodulation Therapy for Negative Symptoms of Schizophrenia
The goal of this clinical trial is to learn if an accelerated form of neuromodulation therapy can help improve negative symptoms of schizophrenia. Negative symptoms can include low motivation, reduced emotional expression, and difficulty with social interaction. The study will also look at how safe and tolerable this treatment is when given over a short period of time. Participants will be randomly assigned to receive either active neuromodulation therapy or sham (placebo) stimulation. The study will also compare two different ways of choosing where to place the stimulation. We want to learn whether this accelerated treatment approach is safe and feasible for people with schizophrenia, whether negative symptoms improve after treatment, and whether the way the stimulation site is chosen affects outcomes Participants will be asked to complete clinical interviews and questionnaires, undergo a brain scan, receive neuromodulation therapy or sham stimulation over five consecutive days, and attend follow-up visits after treatment This study is being conducted at three hospitals in Canada and is designed to help plan larger studies in the future.
Neurophysiologic Biomarkers for Cognitive Rehabilitation
Cognitive symptoms of schizophrenia interfere with daily life-from managing self-care, to more complex tasks like taking medications and living independently. Unfortunately, these cognitive symptoms are not corrected by 'standard of care' treatments (antipsychotic medications), although some schizophrenia patients may experience modest clinical and cognitive benefits from cognitive remediation. To enhance the clinical impact of cognitive remediation and other rehabilitative interventions for Veterans living with chronic psychosis, this study will develop novel brain-based tools to help identify those Veterans who are most likely to benefit from pro-cognitive therapies. These studies may advance predictive algorithms that improve functional outcomes and life quality in Veterans with schizophrenia.