Some problems in the conduct of psychotropic drug trials (a review).
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Biomedical subjects
Publications and source records attributed to M D Parikh.
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We compared acute effects of single intravenous administrations of metoclopramide (40 mg) and placebo in a double-blind crossover study involving 81 patients with tardive dyskinesia. Metoclopramide produced significantly greater reduction in mean total Abnormal Involuntary Movement Scale score as well as in ratings for six of the seven body areas, when compared with placebo. On adjusting each patient's metoclopramide response for his or her placebo response, we found that 35 of the 81 patients had 50% or greater placebo-corrected improvement. There were no apparent clinical differences between metoclopramide responders and nonresponders. Administration of 60 mg of metoclopramide to 15 patients produced greater improvement in tardive dyskinesia as compared with 40 mg; the incidence of acute dystonia, however, jumped from 10% with 40 mg to 33% with 60 mg.
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Twenty-eight male chronic schizophrenic patients completed a 6 month treatment with a single weekly dose of 20 to 120 mg penfluridol, a new long- acting oral neuroleptic. Twenty-four patients showed significant improvement at the end of the trial period. Significant reduction in scores could be demonstrated in 21 out of 26 symptom variables. Central side-effects, reported by 19 patients, were mild and transient except in one patient who was withdrawn from the trial. Laboratory investigations and vital signs remained within normal limits.