Indian study sparks debate on the use of placebo in psychiatry trials

Indian doctors have questioned the ethics of a study in which patients with severe mental illness were given placebo for up to three weeks in eight hospitals across India.

In the double blind, placebo controlled study, which was carried out in 2001, 144 patients received placebo as part of an effort to evaluate the efficacy of the antipsychotic drug risperidone in patients with acute mania.

Hospital ethics committees had approved the study, which was supported by Johnson & Johnson, and doctors had obtained written informed consent from the patients or their legal representatives. The company and the principal investigators of the study have said that only patients whose symptoms were poorly controlled with standard treatment were admitted to the study.

The study found that patients who were given risperidone showed significantly greater improvements than the patients in the placebo group (British Journal of Psychiatry 2005;187: 229-34).

“The study has helped establish the safety and efficacy of risperidone over and above placebo,” said Sumant …