Abstract
How to Perform Phase II Trials in Psychiatry
Highlights
The purpose of the phase II trial is to detect pharmacodynamics activity in the patient and determine the range of active doses
Phase III trials subsequently indicate whether the pharmacodynamics activity is therapeutic
On the basis of the findings of the phase I trial, tolerated doses are studied in the healthy volunteer, generally over the broadest range possible, which may require the participation of a considerable number of patients
Summary
The purpose of the phase II trial is to detect pharmacodynamics activity in the patient and determine the range of active doses. Phase II trials are generally conducted in parallel groups in which three doses of the drug (D1, D2 and D3) are studied versus a placebo and a control product. Phase II trials were often open, non-controlled studies involving few patients. This practice proved unsuitable since the new drug seemed effective in the absence of comparison with a placebo or control product. Except for special cases, the customary practice now is to perform controlled, randomized studies in parallel groups in phase II and later trials [3]
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