Initial treatment of severe acute psychosis with fast orally disintegrating risperidone tablets

An observational study on the use of fast orally disintegrating Risperidone tablets for the treatment of severe acute psychosis has demonstrated rapid and clinically significant resolution of symptoms in affected patients.

Acute severe psychosis is a medical emergency, requiring rapid and effective management. Traditional treatment of acute severe psychosis has included intramuscular injection of high-potency typical neuroleptics. This is associated with several disadvantages, including increased risk of side effects, patient refusal of medication, and mental or physical trauma. In addition, as long-term therapy of psychotic disorders often includes the use of atypical neuroleptics, conversion between agents is then required as the patient enters a maintenance phase. Fast orally disintegrating risperidone tablets have been used for the treatment of schizophrenia. They may also offer an effective oral alternative for the acute management of psychosis.

The study

In this multi-centre, prospective, open-labelled observational study, researchers studied the use of fast acting orally disintegrating risperidone tablets for the treatment of acute psychosis. The study followed 191 patients who presented with a severe acute psychosis. 152 of these patients had an ICD-10 diagnosis of paranoid-hallucinatory schizophrenia, with other diagnoses including schizoaffective disorder, other forms of schizophrenia, acute psychotic disorder, and drug induced psychosis.

Therapeutic effects were assessed using the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impressions Scale for Severity (CGI-S) and Change (CGI-G).

Patients received a median dose of 2 mg/day at the beginning of the study, and 4mg/day at one week.

Results

Risperidone was found to be clinically effective in the treatment of acute severe psychosis. At presentation, PANSS total scores were 114.3 +/- 23.4. At seven days, the PANSS score was significantly reduced to 83.6 +/- 26.8 (p < 0.0001). CGI scores were significantly reduced from 5.6 +/- 0.7 at the commencement of the study to 4.5 +/- 1.1 (P < 0.0001) at 7 days. Risperidone was also fast-acting, with a median time to calmness of 70 minutes after administration.

Co-medication

Co-medication was permitted in this study. 72.8% of patients received one other psychotropic medication, the commonest being lorazepam (50.8%). Analysis of this co-medicated subgroup found that patients receiving a benzodiazepine in addition to risperidone had a more rapid acute response. The median time to calmness in this group was 65 minutes, compared to 90 minutes for patients with risperidone monotherapy. At one week, however, there was no significant difference in total PANSS or CGI-S scores between the two groups. This indicates that risperidone is safe and effective for use in combination with benzodiazepines.

Side effects

21.5% of patients experienced adverse events during the study. Of these, the commonest were extrapyramidal disorders, hypotension and obstipation. Only three patients of 191 discontinued risperidone treatment due to adverse events.

Conclusions

Fast orally disintegrating risperidone tablets are a safe, rapid and effective oral treatment for acutely exacerbated schizophrenic patients. This treatment provides an alternative to the use traditional high-potency neuroleptics, and is associated with significant advantages, including the avoidance of intramuscular injection.

Reference 

Normann C, Schmaub M, Bakri N et al. Initial treatment of severe acute psychosis with fast orally disintegrating risperidone tablets. Pharmacopsychiatry 2006; 39: 209-12.