Introduction: Although the use of atypical antipsychotics is the standard of care in the maintenance treatment of psychosis, most clinicians still rely on conventional neuroleptics to treat acutely agitated psychotic patients. The objective of this study was to evaluate the effectiveness and safety of a fast orally disintegrating tablet formulation of risperidone in the initial treatment of a large sample of very acutely ill psychotic patients.
Methods: In this multi-center, prospective, open-label observational trial, 191 schizophrenic patients were treated upon admission to hospital with fast orally disintegrating risperidone tablets for up to seven days. Co-medication was per usual clinical practice and at physician's discretion. Psychopathology was rated at baseline, 2, 24 and 48 hours and 4 and 7 days after initiation of therapy.
Results: A mean PANSS total score of 114.3+/-23.4 at baseline reflected a severely exacerbated patient population. The PANSS total score was significantly reduced to 83.6+/-26.8 (p<0.0001) and the CGI from 5.6+/-0.7 to 4.5+/-1.1 (p<0.0001) after 7 days. The median time to calmness was 70 min and the associated PANSS item 4 (excitation) dropped two hours after the first intake of the study medication from 4.3+/-1.5 to 3.1+/-1.5 (p<0.0001). A total of 172 patients (90.1%) out of 191 completed the study. The median risperidone dose was 2 mg/d at the initiation of therapy and 4 mg/d after one week.
Conclusion: Oral treatment of acutely exacerbated schizophrenic patients with fast orally disintegrating risperidone tablets, alone or in combination with benzodiazepines, was associated with a rapid onset of action and a significant and clinically relevant improvement of acute symptoms.