Comparison of Risperidone Orodispersible Tablet and Intramuscular Haloperidol in the Treatment of Acute Psychotic Agitation: A Randomized Open, Prospective Study

Abstract

Objectives: Psychotic agitation of psychiatric patients is a common manifestation that needs emergent management. Traditionally, parenteral or intramuscular injection of antipsychotics was conducted for treatment of psychotic agitation. Considering that the rapidly absorbed form of risperidone (risperidone orodispersible tablet) could be used for the agitated patient, comparison of oral risperidone and intramuscular haloperidol was performed in emergency treatment of psychotic agitation in this study. Methods: 124 patients with psychotic agitation were recruited at the emergency room or inpatient ward. They were randomly assigned to either the group of oral risperidone or intramuscular haloperidol. Efficacy of both treatments was measured and compared using the 5-item acute agitation cluster from the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) and the Clinical Global Impression-Severity of Illness Scale (CGI-S). Tolerability and safety were also compared between the two groups. Results: The PANSS-EC and CGI-S scores were significantly decreased over time in both treatment groups without any significant group difference and time by group interaction effect (F = 459.7, p < 0.0001). There were no serious adverse events in both groups. Conclusion: For the emergency treatment of psychotic agitation, risperidone orodispersible tablet was as effective and tolerable as intramuscular administration of haloperidol. Therefore, we might choose oral medication instead of intramuscular injection for treatment of patients with acute psychotic agitation.

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

“…Because of the strength of evidence for efficacy in alleviating agitation in this population, aripiprazole IM (level 2),125, 126 lorazepam IM (level 2),125, 127 loxapine inhaled (Level 1)128, 129 and olanzapine IM (level 2)127, 130, 131, 132, 133 are recommended as the first‐line option. Sublingual asenapine (level 3),134 haloperidol IM (level 3),131, 135, 136 haloperidol IM + midazolam IM (level 3),131, 137 haloperidol IM + promethazine IM (level 3),131, 137, 138 risperidone ODT (level 3),136 and ziprasidone IM (level 3)131, 137, 139 are recommended as a second‐line treatment. Haloperidol per os (PO) (level 4),140, 141 loxapine IM (level 4) (clinical opinion), quetiapine PO (level 4),141 and risperidone PO (level 4)140 are included as third‐line options (Table 11).…”

Are Oral Medications Effective in the Management of Acute Agitation?

“…No articles meeting the inclusion and exclusion criteria were obtained that involved the use of oral ziprasidone or oral aripiprazole. Thus, 11 articles were included for final analysis (6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16). For details, please see Table 1.…”

“…All involved oral antipsychotics. Six studies directly compared oral medications to IM medications (6,7,9,11,12,16). Four studies compared different oral medications to one another (8,10,14,15).…”

Rapid tranquilization of severely agitated patients with schizophrenia spectrum disorders: a naturalistic, rater-blinded, randomized controlled study with oral haloperidol, risperidone, and olanzapine

“…12,13,27 The main limitation of this study is the limited number of participants, which is not sufficient to support noninferiority conclusions of 1 of the antipsychotic agents used. Furthermore, the acute and agitated presentation at baseline prevented us from conducting comprehensive assessments of psychosocial function or pretreatment motor disorders.…”

“…The severity of agitation as measured with the PANSS-EC is in the same range as reported in 1 controlled trial and 3 observational studies 10,13,24,27 but clearly higher than in most controlled trials. 11,12,14 We have used higher PANSS cutoff scores for inclusion than the cutoff used in most other studies.…”