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Pharmacopsychiatry 2006; 39(6): 209-212
DOI: 10.1055/s-2006-950498
Original Paper

© Georg Thieme Verlag KG Stuttgart · New York

Initial Treatment of Severe Acute Psychosis with Fast Orally Disintegrating Risperidone Tablets

C. Normann 1 , M. Schmauß 2 , N. Bakri 3 , M. Gerwe 4 , A. Schreiner 4
  • 1Department of Psychiatry and Psychotherapy, University of Freiburg, Freiburg, Germany
  • 2Department of Psychiatry, Bezirkskrankenhaus Augsburg, Augsburg, Germany
  • 3Department of Psychiatry, Sonnenberg Kliniken Saarbrücken, Saarbrücken, Germany
  • 4Janssen-Cilag, Department of Medical and Scientific Affairs, Neuss, Germany
Further Information

Publication History

Received 8. 3. 2006 Revised 10. 7. 2006

Accepted 19. 7. 2006

Publication Date:
23 November 2006 (online)

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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.

References

  • 1 Allen MH, Currier GW, Carpenter D, Rose RW, Doherty JP. Treatment of behavioral emergencies 2005.  J Psychiatr. Pract. 2005;  11 ((Suppl 1)) 5-108
    Search in Google Scholar
  • 2 Breier A, Meehan K, Birkett M, David S, Ferchland I, Sutton V, Taylor CC, Palmer R, Dossenbach M, Kiesler G, Brook S, Wright P. A double-blind, placebo-controlled dose-response comparison of intramuscular olanzapine and haloperidol in the treatment of acute agitation in schizophrenia.  Arch Gen Psychiatry. 2002;  59 441-448
    CrossrefPubMedSearch in Google Scholar
  • 3 Brook S, Luvcey JV, Gunn KP. Intramuscular ziprasidone compared with intramuscular haloperidol in the treatment of acute psychosis. Ziprasidone I.M. Study Group.  J Clin Psychiatry. 2000;  61 933-941
    CrossrefPubMedSearch in Google Scholar
  • 4 Chue P, Welch R, Binder C. Acceptability and disintegration rates of orally disintegrating risperidone tablets in patients with schizophrenia or schizoaffective disorder.  Can J Psychiatry. 2004;  49 701-703
    PubMedSearch in Google Scholar
  • 5 Currier GW, Simpson GM. Risperidone liquid concentrate and oral lorazepam versus intramuscular haloperidol and intramuscular lorazepam for treatment of psychotic agitation.  J Clin Psychiatry. 2001;  62 153-157
    PubMedSearch in Google Scholar
  • 6 Czobor P, Volavka J, Meibach RC. Effect of risperidone on hostility in schizophrenia.  J Clin Psychopharmacol. 1995;  15 243-249
    CrossrefPubMedSearch in Google Scholar
  • 7 Hillard JR. Emergency treatment of acute psychosis.  J Clin Psychiatry. 1998;  59 ((Suppl 1)) 57-60
    PubMedSearch in Google Scholar
  • 8 Hovens JE, Dries PJ, Melamn CT, Wapenaar RJ, Loonen AJ. Oral risperidone with lorazepam versus oral zuclopenthixol with lorazepam in the treatment of acute psychosis in emergency psychiatry: a prospective, comparative, open-label study.  J Psychopharmacol. 2005;  19 51-57
    CrossrefPubMedSearch in Google Scholar
  • 9 Kinon BJ, Hill AL, Liu H, Kollack-Walker S. Olanzapine orally disintegrating tablets in the treatment of acutely ill non-compliant patients with schizophrenia.  Int J Neuropsychopharmacol. 2003;  6 97-102
    CrossrefPubMedSearch in Google Scholar
  • 10 Lejeune J, Larmo I, Chrzanowski W, Witte R, Karavatos A, Schreiner A, Lex A, Medori R. Oral risperidone plus oral lorazepam versus standard care with intramuscular conventional neuroleptics in the initial phase of treating individuals with acute psychosis.  Int Clin Psychopharmacol. 2004;  19 259-269
    PubMedSearch in Google Scholar
  • 11 Levy RH. Sedation in acute and chronic agitation.  Pharmacotherapy. 1996;  16 152S-159S
    PubMedSearch in Google Scholar
  • 12 Raedler TJ, Schreiner A, Naber D, Wiedemann K. Risperidone in the treatment of acute schizophrenia.  J Clin Psychopharmacol. 2004;  24 335-338
    PubMedSearch in Google Scholar
  • 13 Van Schaick EA, Lechat P, Remmerie BM, Ko G, Lasseter KC, Mannaert E. Pharmacokinetic comparison of fast-disintegrating and conventional tablet formulations of risperidone in healthy volunteers.  Clin Ther. 2003;  25 1687-1699
    CrossrefPubMedSearch in Google Scholar
  • 14 Yildiz A, Sachs GS, Turgay A. Pharmacological management of agitation in emergency settings.  Emerg Med J. 2003;  20 339-346
    CrossrefPubMedSearch in Google Scholar

Correspondence

Claus NormannMD 

Department of Psychiatry and Psychotherapy·University of Freiburg

Hauptstr. 5

79104 Freiburg

Germany

Phone: +49/761/270 6501

Fax: +49/761/270 6619

Email: claus.normann@uniklinik-Freiburg.de