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The Journal of Clinical Pharmacology and New Drugs, 1970; 10:175-181
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Clinical Pharmacological Trial of Loxapine Succinate

A Cooperative Study by Four Clinical Drug Evaluation Units of the Psychopharmacology Research Branch, National Institute of Mental Health. Bethesda Md.

A. Wolpert 1, L. White 1, L. Dana 1, A. A. Sugerman 2, A. D. Arengo 3, G. M. Simpson 3, M. P. Bishop 4, and D. M. Gallnt 4

1 Central Islip State Hospital, Central Islip, N.Y.
2 New Jersey Neuropsychiatric Institute, Princeton, N.J.
3 Rockland State Hospital, Orangeburg, N.Y.
4 Tulane University, New Orleans, La.

In an open study loxapine succinate was given to 44 subjects in four different Early Clinical Evaluation Units. The results of the studies were remarkably consistent and all investigators agreed on the activity of this preparation. This was confirmed by the nurses in all four units and received support from the BPRS in three of the units.

A dose range of 40 to 200 mg was employed, but a suggested dose range of 40 to 100 mg was put forward. Side effects consisted of drowsiness, hypotension (one subject), and extrapyramidal disorders. These latter were similar to those seen with other compounds and did not necessitate withdrawal of any subject from the trial. It was concluded by all investigators that loxapine possessed neuroleptic properties. None of the four trials revealed significant toxicity.

Note:

The authors wish to thank Dr. H. Kiltie of Lederle Laboratories for supplies of loxapine succinate.


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