Randomized controlled study of olanzapine oral soluble film versus intramuscular haloperidol against agitated behaviour in male inpatients with schizophrenia

Abstract

BackgroundAgitated behaviour in male patients with schizophrenia can lead to serious consequences for the individual and the society. Non-invasive drug delivery may help to rapidly control agitation and improve the overall patient satisfaction， but there are limited studies on the efficacy of olanzapine oral soluble film for the treatment of agitated behaviour in patients with schizophrenia.ObjectiveTo compare the efficacy and safety profile of olanzapine oral soluble film versus intramuscular haloperidol against agitated behaviour in male patients with schizophrenia， so as to provide a reference for the treatment of agitated behaviour.MethodsFrom May 2022 to July 2023， a consecutive sample of schizophrenic patients （n=44） with agitated behaviour who met the Diagnostic and Statistical Manual of Mental Disorders， fifth edition （DSM-5） were recruited in the male psychiatric closed ward of the Third People's Hospital of Fuyang. Patients were assigned into two groups using the random number table method， each with 22 cases. Study group was treated with olanzapine oral soluble film 10 mg/d， while control group was given intramuscular haloperidol 8 mg/d. The severity of agitated behaviour was determined using Positive and Negative Syndrome Scale-Excited Component （PANSS-EC） and Agitation Calmness Evaluation Scale （ACES） at the baseline and after 6 h of drug administration. The treatment response rate was calculated based on the reduction of PANSS-EC score， and the drug side effects were assessed using Rating Scale for Extrapyramidal Side Effects （RSESE） and Barnes Akathisia Rating Scale （BARS） after 6 h of drug administration.ResultsAfter 6 h of drug administration， no statistical difference was reported in PANSS-EC score and ACES score between two groups （F=0.039， 0.082， P>0.05）， and the treatment response rate yielded no statistical difference between two groups （χ2=0.419， P=0.517）， while study group reported a lower incidence rate of adverse reactions compared with control group， with statistically significant difference （P=0.031）. BARS scores noted no statistical significant difference between two groups （t=0.587， P=0.561）， whereas study group scored lower on RSES compared to control group， with a statistical difference （t=-7.367， P<0.01）.ConclusionIn the treatment of agitation in male patients with schizophrenia， the efficacy of olanzapine oral soluble film is comparable to that of intramuscular haloperidol， while the safety profile of the former is superior to that of the latter. ［Funded by Scientific Research Project of Fuyang Municipal Health Commission （number， FY2021-147）， Anhui Provincial Medical and Healthcare Key Speciality Construction Project （number， 〔2021〕273）； www.chictr.org.cn number： ChiCTR2200063052］

Keywords

• olanzapine oral soluble film
• haloperidol injection
• schizophrenia
• agitation