Comparing the efficacy of atypical antipsychotics in open uncontrolled versus double-blind controlled trials in schizophrenia

Abstract

Although double-blind controlled studies are essential in the investigation of new compounds, results of methodologically well-performed open studies are valid and deserve more attention. Preceding open trials may help in the design of double-blind studies.

Risperidone

“…9,11,35 However, the differences between open and controlled clinical trials have not been found to be statistically significant. 32 In any case, these effects are most likely not restricted to risperidone. An Australian study with a naturalistic design concluded that both risperidone and olanzapine, in combination with benzodiazepines, were effective in treating patients with severe psychosis.…”

“…these patients, they can also provide important additional information in an area in which more research is greatly needed. [30][31][32] On the other hand, the typical limitations of observational studies need to be accepted and have to be considered when the results are interpreted. These include the possibility of biased results, for example, because of a selection of patients, nonblinded raters and underlying interests of sponsors, or the possible difficulty of comparing results with those of randomized trials due to a lack of standardization of patients or treatments.…”

Validation of the Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC) in a naturalistic sample of 278 patients with acute psychosis and agitation in a psychiatric emergency room

“…The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation [7]. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients [5,7-10] with different psychiatric pathologies [7,8,11-18]. …”