“Half of the clinical studies of potential pharmacologic interventions to prevent olanzapine-associated weight gain have been negative, at huge expense. We hope that this approach will help identify drugs with a better chance of working,” lead investigator James L. Roerig, PharmD, from the University of North Dakota School of Medicine, in Fargo, told Medscape Psychiatry.
The method developed by Dr. Roerig and colleagues uses brief placebo-controlled trials with normal volunteers to determine whether a prospective treatment drug deserves study in clinical trials.
The process starts with a brief trial to show that the main treatment agent will produce the target adverse effect in normal volunteers; it is followed by a short placebo-controlled study to see whether adding the candidate drug reduces the adverse effect enough in normal volunteers to signal that the test drug is likely to work and deserves further study.