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.
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.