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The Journal of Clinical Pharmacology and New Drugs, 1972; 12:26-34
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An International Double-Blind Clinical Evaluation of Pimozide

Paul Janssen M.D.1, Jo Brugmans M.D.1, Jean Dony 1, and Viviane Schuermans 1

1 Janssen Pharmaceutica, Research Laboratoria, B-2340 Beerse, Belgium.

Pimozide, a neuroleptic of the diphenylbutylpiperidine series, was studied in an international collaborative trial using standard protocols. The trial involved 180 chronic psychotic patients studied in 36 psychiatric institutions in 8 countries, 3 continents. All 180 patients had shown signs of clinical deterioration within four weeks of withdrawal of classical maintenance neuroleptic treatment and had improved after reinstitution of classical neuroleptics. Pimozide, in a single daily dose (median dose: 6 mg) and as the sole drug was substituted for classical medication comprising multiple drugs and drug combinations in optimal dosage. Of 154 patients who improved markedly, 141 entered a placebo-controlled double-blind study: 84 of them relapsed within the predicted four weeks of discontinuation of pimozide (P=9.8X10-25, binomial theory). Statistical analyses of the 36-item rating scales for the 84 patients who completed the study successfully and the 26 patients who deteriorated during pimozide treatment showed that pimozide produced additional benefits in patients who were sensitive to the antipsychotic and socializing effects of classical neuroleptics whereas patients who did not respond to the incisive effects of neuroleptics but presumably benefited from their restraining or sedative effects deteriorated when treated with pimozide.

Pimozide appeared to be the drug of choice for the long-term maintenance treatment of chronic psychotic patients who are responsive to the specific antipsychotic and socializing effects of neuroleptics and for whom social rehabilitation is envisaged.

Note:

It is a pleasure to thank Drs. R. E. Bauling, W. J. Forgiel, H. Malmgren, H. C. Masheter, V. Oberhauser, E. E. Scharenberg, and H. von Loeper for their active interest and cooperation during these studies.


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Copyright © 1972 by the American College of Clinical Pharmacology