Effects of control techniques on therapeutic outcome in a controlled clinical trial.

Undertaken in the context of a controlled drug trial involving newly admitted psychiatric hospital patients, this study compared the effectiveness of a "Doctor's Choice" (DC) method of administering psychotropic drugs versus an experimentally determined treatment regimen employing random assignment and double-bline procedures. The 32-day drug trial sought to determine the comparative effectiveness of thioridazine-placebo, thioridazine-chlordiazepoxide, and thioridazine-imipramine, with the daily dosage of openly administered thioridazine ranging from 100 to 900 mg and dosages for chlordiazepoxide and imipramine, administered in a double-blind fashion, fixed at daily dosages of 30 and 75 mg, respectively. DC medication, consisting of a choice (by a research physician) of any of the three experimental medications determined on the basis of judged clinical need, was added as a fourth treatment category for present purposes. Criteria of effectiveness included standarized psychiatric rating scales and global measures of imporvement completed by research team members and ward physicians. Outcome results for the DC group compared to those for a single control group made up of individuals matched with DC patients on the basis of drug assignment indicated an essentially similar clinical effectiveness under both DC and control treatment conditions. Generalization of the finding was limited by the fact that the main treatment effect, attributable to thioridazine, overshadowed the more subtle action of the ancillary drugs.

RCT Entities:   Population Interventions Outcomes