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With any medication, standard marketed drugs or investigational drugs, there is always some risk of adverse side effects. For this reason, patients entered into psychotropic research trials are required to be in excellent health and in a certain age range. (Females of child-bearing age may/may not participate.) Numerous safety evaluations are completed and the results are reviewed by a highly qualified medical team prior to dispensing the medication. Physical examinations, electrocardiograms, blood work, and a detailed medical and psychiatric history are all required along with the patient’s signed consent In addition, each patient’s progress is monitored very closely by the research team, the pharmaceutical company’s clinical team, the investigational review board (IRB) and the FDA.

Possible side effects are explained in advance and patients are able to report these problems any time, night or day. If these side effects pose a risk to die patient, or are too bothersome, discontinuation of medication would be immediately recommended. If during the study, investigators see unexpected adverse effects in their patients, this information is immediately reported to the drug company, which in turn may stop the drug and inform the FDA, if indicated.

All in all the high degree of monitoring means that the risk is minimal. Once in a while, however, problems do occur.

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