Factors associated with clinician assessment may play a role in the increasing rate of failed trials. The use of centralized raters, a small group of highly skilled, tightly calibrated, and continuously monitored raters linked to the study sites through videoconferencing can address these issues by reducing the sheer number of raters involved, using rigorous calibration procedures not logistically feasible with a larger dispersed group of raters, and by blinding raters to visit and protocol. This phase 2 study was the first randomized controlled trial to use centralized raters in a study of treatments for schizophrenia. Subjects (N = 313) from 32 sites were randomly assigned to 6weeks of treatment with 1 of 2 doses of an investigational antipsychotic, olanzapine 15 mg, or placebo. Subjects were evaluated weekly using the Positive and Negative Syndrome Scale. Datafrom the olanzapine (n = 68) and placebo (n = 68) arms were provided by the sponsor. The mean Positive and Negative Syndrome Scale change was significantly greater with olanzapine (−15.2) than placebo (−4.43), P = 0.002. The significant difference was apparent at week 1. The effect size was 0.48. Internal consistency was high throughout the study. Scores at screening were normally distributed and not skewed toward the cutoff score. Results found that hospitalized patients with schizophrenia were willing and able to participate in clinical trials using remote interviews conducted via videoconference. This methodology shows enormous promise for use in clinical trials, even with acutely psychotic patients.
*Wyeth Research, Collegeville, PA; †MedAvante Inc, Hamilton, NJ; and ‡The Zucker Hillside Hospital, Glen Oaks, NY; and The Albert Einstein College of Medicine, Bronx, NY.
Received March 24, 2008; accepted after revision September 3, 2008.
This project was funded by Wyeth Pharmaceuticals.
Address correspondence and reprint requests to Kenneth A. Kobak, PhD, MedAvante Inc, 100 American Metro Blvd, Suite 106, Hamilton, NJ, 08619. E-mail: email@example.com.