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P&S Journal

P&S Journal: Fall 1995, Vol.15, No.3
Clinical Trials: Recruitment, Sometimes Easy Sometimes a Thankless Task. The Adventures of Six Clinicians Recruiting Patients for Trials By Lynne Christensen;
Dr. Brian Fallon, Hypochondria

Dr. Brian Fallon in the clinic where he conducted a placebo-controlled study of IV clomipramine for obsessive-compulsive patients.

When a psychiatrist tested a drug for obsessive-compulsive behavior, patients flew in from all over the country while other eager participants were put on a waiting list. But the researcher has difficulty recruiting patients to test a drug for their hypochondria, a diagnosis they resist.
Some clinical trials study approved drugs for a new indication. Dr. Brian Fallon, assistant professor of clinical psychiatry, is studying whether the antidepressant medication Prozac can be used to help hypo- chondriacs overcome their fears. One of several obstacles he faces in enrolling patients is that Pro-zac is an approved drug, and any doctor who hears that it may be helpful for hypochondria can simply prescribe it, without referring the patient to Dr. Fallon's study.

Dr. Fallon also faces the challenge of convincing hypochondriacs who believe they have a medical problem to consult a psychiatrist and thus confront the psychosomatic nature of their condition.

Widely publicized warnings about potentially dangerous side effects of Prozac also render recruitment difficult. "Hypochondriacs tend to be very fearful about life in general and may be particularly fearful about taking a medication that has received any negative publicity," says Dr. Fallon.

Dr. Fallon finds that patients with serious medical or psychiatric illnesses are most inclined to participate in clinical trials if the treatment is not available elsewhere and if the patient believes there is hope it will work. For a placebo-controlled trial of IV clomipramine (a tricyclic antidepressant) for obsessive-compulsive behavior, Dr. Fallon had a six-month waiting list and patients flew in from all over the country to try it.

The drug is available in oral form, but 20 percent of patients who take it do not respond. The only other option has been a surgical procedure that is sometimes successful. Dr. Fallon theorized that patients who are refractory to the oral form of clomipramine might respond to IV administration of the drug. Like Dr. Fahn, Dr. Fallon offered patients in the control group the opportunity to have the active treatment once the study was completed.

The IV form of the drug proved to be effective compared with a placebo. Now Dr. Fallon is planning a study to compare the IV form with the oral form.

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