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Clozapine in drug induced psychosis in Parkinson’s disease: a randomised, placebo controlled study with open follow up
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  1. P Pollak1,
  2. F Tison2,
  3. O Rascol3,
  4. A Destée4,
  5. J J Péré5,
  6. J M Senard3,
  7. F Durif6,
  8. I Bourdeix5,
  9. on behalf of the French Clozapine Parkinson Study Group
  1. 1Department of Neurology, University Hospital of Grenoble, 38043 Grenoble Cedex 9, France
  2. 2Fédération de Neurologie, University Hospital of Bordeaux, 33604 Pessac, France
  3. 3Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U455, CHU Purpan, 31073 Toulouse University Hospital, France
  4. 4Neurology and Movement Disorders Unit, Neurologie A, Hôpital Salengro, 59037 Lille, France
  5. 5Novartis Pharma, 92506 Rueil-Malmaison, France
  6. 6Fédération de Neurologie, Hôpital Gabriel Montpied, 63033 Clermont-Ferrand Cedex I, France
  1. Correspondence to:
 Dr P Pollak
 Départment de Neurologie, Centre Hospitalier Universitaire de Grenoble, BP 217 X, 38043 Grenoble Cedex 9, France; pierre.pollakujf-grenoble.fr

Abstract

Objective: To compare the efficacy and safety of clozapine in drug induced psychosis in Parkinson’s disease (PD).

Methods: A four week, randomised, double blind, parallel comparison of clozapine and placebo, followed by a 12 week clozapine open period, plus a one month period after drug discontinuation, in 60 patients with PD. The primary efficacy outcome was the “clinical global impression scale” (CGI); the positive subscore of the “positive and negative syndrome scale” (PANSS) was used as the secondary efficacy parameter and the “unified Parkinson’s disease rating scale” (UPDRS) and the “mini mental test examination” (MMSE) as safety outcomes.

Results: The mean (SD) dosage of clozapine was 35.8 (12.5–50) mg at the end of the double blind period. The mean (SD) scores on the CGI improved by 1.8 (1.5) for the clozapine group compared with 0.6 (1.1) for the placebo group (p  =  0.001). The mean (SD) positive subscore of PANSS improved by 5.6 (3.9) for the clozapine group (0.8 (2.8) for the placebo group; p < 0.0001). At the end of the open period, 25 patients had completely recovered from delusions and hallucinations, and 19 experienced a relapse within one month after the clozapine washout period. The UPDRS motor and MMSE mean scores did not change significantly in either group. Somnolence was more frequent with clozapine than with placebo.

Conclusions: Clozapine at a mean dose lower than 50 mg/day improves drug induced psychosis in PD without significant worsening of motor function, and the effect wears off once the treatment stops.

  • Parkinson’s disease
  • psychosis
  • clozapine
  • CGI, clinical global impression scale
  • MMSE, mini mental test examination
  • PANSS, positive and negative syndrome scale
  • PD, Parkinson’s disease
  • UPDRS, unified Parkinson’s disease rating scale

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Footnotes

  • Competing interests: PP has been reimbursed for expenses related to conferences, has received fees for speaking, and was once a consultant at the EMEA for Novartis. FT has been paid as an investigator in the present study and has been invited to several conferences by Novartis Pharma SA. OR and AD have been reimbursed for attending several conferences and received speaking fees from Novartis, the manufacturer of clozapine. JJP and IB are employees of Novartis, the sponsors of the study.

  • The French Clozapine Parkinson Study Group. Safety committee: J M Senard, Hôpital Purpan, Toulouse; V Lamarque, Novartis Pharma Rueil-Malmaison; and V Dev, Novartis Pharma Basle. Others members: Y Agid, Hôpital de la Salpêtrière, Paris; H Allain, CHU Rennes; M Borg, Hôpital Pasteur, Nice; E Broussolle, Hôpital Neurologique, Lyon; F Durif, Hôpital Gabriel Montpied, Clermont-Ferrand; C Geny, Centre Hospitalier Général, Pau; C Prunier-Levilon, CHU Bretonneau, Tours; S Sangla, Hôpital Delafontaine, Paris; M Vérin, CHU, Rennes; F Viallet, Hôpital Général, Aix-en-Provence; C Tranchant, Hôpital Civil, Strasbourg.

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