- 23 Mar 2009
Free drug trials are advertised on radio and television and in the newspapers. Upon telephoning the investigator, a potential participant in one of these trials would undergo a ten-minute screening interview on the phone, during which the new drug, the nature of the study, and the possibility of being assigned to a placebo would be explained, along with the rights of patients who volunteer, including the right to discontinue the drug at any time. If the screening interview looks promising, the patient is asked to come in for a more detailed psychiatric interview. Thereafter, a medical exam, including an EKG, is performed to see if the patient is truly eligible. If the patient meets the criteria, he or she is asked to sign a one or two-page informed consent document about the study.
Clinical drug studies generally fall into three categories. In phase I studies, patients in the hospital are treated with drugs in their earliest state of clinical development to determine dosages and safety. In phase II studies, both hospitalized patients and outpatients are given low, medium, or high doses to check for efficacy, tolerance, and side effects. In phase III studies, investigators usually compare the new drug to a placebo and to one or two other standard drugs that have been marketed for several years. Large numbers of outpatients in eight to ten centers throughout the country participate thereafter in a six-to eight-week trial. Most new drug studies go through these final phases of development prior to I approval by the PDA for marketing. In phase IV, drug studies take place after marketing in order 10 investigate the medication’s potential usefulness with diseases other than the initial illness for which the FDA gave its approval. The people who participate in these antidepressant trials may include treatment-resistant patients who have tried other antidepressants, including tricyclics, MAOIs and SSRIs, all without success. For them a new drug trial is the court of last appeal. The lack of cost to the participants and the extraordinary attention they receive from highly qualified doctors and nurses are major factors in the patient’s motivation to participate.
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- Tags: Anti Depressants
- Category: Anti Depressants-Sleeping Aid