Attitudes of Patients With Schizophrenia Toward Placebo-Controlled Clinical Trials

Dropout Rates in Placebo-Controlled and Active-Control Clinical Trials of Antipsychotic Drugs

“…Second, considering the patients' view, it has been shown in independent investigations that their willingness to participate in a study is negatively affected when being informed that the study is placebo controlled. 10 Although patient refusal to participate in a study and patient-induced dropout are 2 distinct matters, they may well be related. Therefore, a patient with a reserved attitude toward PCTs may possibly be convinced by the treating physician to participate in such a trial but may not be prepared to endure longer periods with few or no signs of improvement.…”

“…Because other difficulties in performing PCTs have been reported, particularly regarding the willingness to participate in such a trial, 8,10 second-best alternatives need to be contemplated. The ACT, that is, a clinical trial with 1 or several active comparators, would seem to be the most obvious alternative, once an efficacious active treatment has been established as a standard.…”

Placebo controls in clinical trials: concerns about use in relapse prevention studies in schizophrenia

“…Patients who are sceptical about the long term use of antipsychotics are more likely to agree to participate-indeed, fear of relapse was cited as one of the main reasons for patients not participating in a placebo controlled study. 17 Also, many investigators refuse to participate in such trials, citing ethical concerns as the reasons. 18 A further concern is that the high dropout rates in clinical trials using placebo controls 19 reduce their statistical power.…”

Reviews: Emerging Empirical Evidence on the Ethics of Schizophrenia Research

“…88,123,165 Similarly, Hummer and colleagues indicate that concerns about potential risks associated with a placebo-controlled trial were a disincentive to participate for over half the patients surveyed. 166 In some cases, efforts to inform participants about the risks of specific protocols appear to need more work. For example, in a relatively low-risk protocol, researchers found that, compared with healthy controls, middle-aged and older patients with schizophrenia had more difficulty responding to an open-ended question about the potential risks of enrolling.…”