Trial of risperidone in India – concerns

The study by Khanna et al (2005) on the effectiveness of risperidone in acute mania raises many questions.

Why was the study done? The authors do not indicate that existing treatments have limitations that led them to test risperidone as an alternative.

Why was a placebo used when an effective treatment exists? This is particularly worrisome because, as the authors state, acute mania can be life-threatening and carries an increased risk of suicide.

Patients undergoing psychiatric treatment are a vulnerable group. How did patients give informed consent during an episode of acute mania?

Where were the trial sites? Who were the participants and what quality of care did they receive? What were the adverse events? How were seven participants from the placebo group lost to follow-up?

Regarding the ‘wash-out’ period before the trial, is it medically and morally justified to withhold treatment from patients during an episode of illness in intensive care?

Four authors state that they are drug company employees. Do the other authors have any competing interest to declare?

In what sense was the trial conducted according to the Declaration of Helsinki? Why do the authors mention the Declaration as revised in 1989, rather than a more recent revision?

We suggest that this trial could not have been conducted in a high-income country but may have been conducted in India because regulatory requirements could be fulfilled there. The use of a placebo when an effective treatment exists – and other elements of the study as mentioned above – goes against the Helsinki guidelines and those of the Indian Council of Medical Research (2000). Finally, publication of such studies in a leading journal such as the British Journal of Psychiatry gives credibility to unethical medical research and practice and is a matter of serious concern.