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Efficacy and Safety of Risperidone Microspheres for Injection (II) in Patients With Schizophrenia Spectrum Disorders:
Wei Li1, Jinghui Tong1, Xiaoxiao Gao1
1Peking University HuiLongGuan Clinical Medical School, Beijing HuiLongGuan Hospital, 100096 Beijing, China.
Alpha Psychiatry
|May 11, 2026
Summary
Risperidone Microspheres for Injection (II) (RMI-II) effectively reduced symptoms in schizophrenia spectrum disorders (SSD). This long-acting injectable antipsychotic showed significant improvements in patient scores and well-tolerated safety profiles over 12 weeks.
Area of Science:
- Psychiatry
- Pharmacology
- Clinical Medicine
Background:
- Long-acting injectable (LAI) antipsychotics are crucial for managing schizophrenia spectrum disorders (SSD), improving treatment adherence and long-term patient recovery.
- Risperidone Microspheres for Injection (II) (RMI-II) is a novel LAI formulation designed for rapid symptom control with a 2-week dosing schedule.
- Limited real-world data exists on the efficacy and safety of RMI-II in SSD patients.
Purpose of the Study:
- To evaluate the real-world efficacy and safety of Risperidone Microspheres for Injection (II) (RMI-II) in patients with schizophrenia spectrum disorders (SSD).
- To assess the impact of RMI-II on symptom reduction, clinical response, and remission rates over a 12-week treatment period.
- To determine the tolerability and adverse event profile of RMI-II in a diverse patient population.
Main Methods:
- A prospective, single-arm, multicenter study involving 228 patients diagnosed with SSD according to DSM-5 criteria.
- Patients received intramuscular injections of RMI-II at doses of 25-50 mg every 2 weeks for a total of 12 weeks.
- The Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity (CGI-S) Scale were used to assess symptom severity and clinical improvement.
Main Results:
- Significant reductions in PANSS total scores were observed at week 2 (14.02 points, p < 0.001) and week 12 (38.28 points, p < 0.001).
- Clinical response rates increased from 37.1% at week 2 to 83.7% by week 12. Clinical remission was achieved by 68.9% of patients at 12 weeks.
- The CGI-S score improved from a baseline moderate-to-severe level (5.0) to mild-to-moderate (3.0). Adverse events were reported in 15.35% of patients, with hyperprolactinemia and extrapyramidal symptoms being most common (1.3% each).
Conclusions:
- RMI-II demonstrated significant efficacy in reducing acute psychotic symptoms in patients with SSD.
- The LAI formulation was well-tolerated, suggesting it is a viable therapeutic option for managing SSD.
- These findings support RMI-II as an additional treatment choice for schizophrenia spectrum disorders.
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