With a sample size of 290 patients the report by Khanna et al (Reference Khanna, Vieta and Lyons2005) buttresses the data about efficacy of atypical antipsychotics in the treatment of acute mania, but the article also raised the following concerns.
One of the sites had to be withdrawn from the study after enrolling three participants because of concerns about data quality. However, the data from these individuals were still included in the safety analyses. We are of the opinion that if there were concerns about the data from one particular site, then that site should have been excluded from any further analyses.
We also have concerns about the legitimacy and validity of the informed consent obtained from 145 patients with acute mania and a mean Young Mania Rating Scale score of 37.5 to be enrolled in the placebo arm of a clinical trial. Article 4 of the World Medical Association Declaration of Helsinki (World Medical Association, 1989) states that biomedical research involving human participants cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the participant. Delayed treatment of acute mania is associated with considerable acute and long-term morbidity from both illness and its secondary consequences (Reference Post, Sadock and SadockPost, 2000). Randomising a patient with acute mania to the placebo arm of a 3-week trial leads to considerable delay in treatment.
In this trial 145 patients with acute mania were assigned to the placebo arm. We consider it unethical and inhumane to treat 145 patients with acute mania with placebo. All future trials concerning the efficacy of a medication for acute mania should use an arm with one of the proven medications as a comparator and not include a placebo arm.
eLetters
No eLetters have been published for this article.