Douglas Berger Psychiatrist Tokyo, writes a Letter to the Editor in Psychiatric Times (date unknown)
In their article “Are Placebo Controls Ethical in Antidepressant Clinical Trials?” (Psychiatric Times April 2000) Khan and Khan state that the FDA’s double-blind placebo controlled trial requirement for new antidepressant approval is not necessary in Europe or Asia.
In Japan, while there is no guideline specific for antidepressants, this does not mean it can be omitted. The general guidelines for drug development state that double-blind placebo controlled trials are preferred and it would be unthinkable for the Japan Ministry of Health and Welfare to approve a new antidepressant without data from a double-blind placebo controlled trial, either one done in Japan or using the data from a double-blind placebo controlled trial done overseas (no antidepressant in Japan has yet only to bridge overseas Ph 3 data in their NDA package although fluoxetine may attempt to do so in the near future). The only SSRI on the market, fluvoxamine (since May 1999), had two pivotal double-blind placebo controlled trials. Paroxetine, sertraline, and SNRIs have done or are now doing double-blind placebo controlled phase 3 trials.
The EMEA European regulatory body would also not allow approval of a drug that did not have a double-blind placebo controlled pivotal study.
Proof of maintenance efficacy is also required in Europe for antidepressant drug approval.
Doug Berger, M.D., Ph.D.
US Board Certified Psychiatrist
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