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FDA Fast Tracks Mifepristone As Possible Treatment for Psychotic Depression

After a study published in the July 26 edition of the Journal of Biological Psychiatry concluded that mifepristone is effective in treating psychotic depression, the Food and Drug Administration (FDA) announced recently that the drug has been put on fast-track approval – it is the first drug for a psychiatric condition to be fast tracked.

The study, conducted by researchers at Stanford University, found that people who suffer from psychotic major depression were found to improve quickly and with few side effects using mifepristone, also known as RU 486. Mifepristone is commonly known as the “abortion pill” because it has been shown to be a safe and effective way to terminate a pregnancy in its early stages. However, doctors and researchers are discovering other potential uses of mifepristone, including as a possible treatment for uterine fibroids and several types of cancer. “It’s high time that the lifesaving potential of mifepristone has been released from the shackles of anti-abortion politics,” said Dr. Beth Jordon, medical director at the Feminist Majority Foundation.

In the Stanford study, mifepristone was found to dramatically improve more than two-thirds of patients in the medium- and high-dose groups within seven days. Dr. Alan Schatzberg, professor and chair of the psychiatry department at Stanford, said that mifepristone “may be the equivalent of shock treatments in a pill without the morbidity,” according to a Stanford press release. Though electroconvulsive therapy is effective for about 80 percent of the patients who elect to use it, results may not be seen for weeks or months after starting the treatments. A new major study on the use of mifepristone for depression is underway at Stanford.

The other major treatment for psychotic major depression is a combination of antidepressants and antipsychotics, which improve symptoms in roughly 60 percent of cases. However, side effects from mifepristone are very low compared to these combinations of drugs.

Sources:

Business Wire/Health Wire 8/1/02; Feminist Majority 8/2/02

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