Prospective, open-label study to validate proper use of the Versacloz™ (clozapine) oral suspension kit by people with schizophrenia
Anthony D Andre
Interface Analysis Associates, Saratoga, CA, USA
Purpose: This study was designed to validate that people with schizophrenia can correctly, safely, and effectively prepare doses of Versacloz™ using the Versacloz oral suspension kit and instructions for use (IFU).
Materials and methods: This was a prospective, open-label, simulated-use validation study of 61 people with schizophrenia who were stabilized on clozapine or were clozapine-naive and stabilized on another antipsychotic treatment. Participants were randomized to one of two groups: untrained (n=46) and trained (n=15). Participants were asked to select the proper syringe and prepare two test doses of 1, 3.5, or 5 mL, as randomly assigned. Participants in the untrained group did not receive any training on using the kit, but had access to kit materials, including packaging and the IFU; both test dose preparations were unaided. Participants in the trained group received brief training from the moderator, and then prepared one test dose during training and one unaided test dose during the study period. Prepared placebo doses were not ingested. Performance and behavior were assessed in 14 critical tasks identified in the user failure mode and effects analysis. Test dose failures or dose errors (threshold ±0.1 mL) were assessed. Subjective participant assessments of usability were captured in interviews and IFU comprehension was probed.
Results: A total of 107 test doses were prepared: 92 and 15 by the untrained and trained groups, respectively. Overall success for unassisted dose preparation was 87.9%; all test failures (failure to shake the bottle or failure to obtain the correct test dose) occurred in the untrained group. All participants selected the correct syringe for their assigned dose.
Conclusion: This study shows that the Versacloz oral suspension kit and IFU can be correctly, safely, and effectively used to prepare doses by people with schizophrenia, with few instances of failure or errors observed.
Keywords: Versacloz, clozapine, test dose, oral suspension, treatment-resistant schizophrenia
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