Report on the Third Consensus Conference on the Methodology of Clinical Trials with Antipsychotic Drugs

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

“…They are absolutely necessary for research in psychopharmacology, enabling scientific investigation and satisfactory documentation of the safety and efficacy of therapeutic agents (Angst et al 1991;Sprafkin and Gadow 1996;Storosum et al 1998). In particular for the response rate, the most relevant clinical parameter, a placebo-controlled assessment, is mandatory (Storosum et al 1998).…”

“…c. They might help obtain drug-response information in community-based clinical settings. It is known that patients included in controlled studies are highly selected and usually do not represent the individual in the everyday clinical situation (Angst et al 1991;Hofer et al 2000;Klein 1991;Sprafkin and Gadow 1996;Licht et al 1997). Although there are to our knowledge no studies that investigated the potential difference of subjects enrolled to open studies relative to the average in-or out-patient, one might presume a lower discrepancy compared with a double-blind assessment.…”

“…Results of open, uncontrolled psychopharmacological trials in the development and approval of new psychopharmacological drugs are often regarded with doubt (Angst et al 1991). Skepticism focuses on the extent to which factors such as the expectations of the investigator and his attitude toward a new pharmacological compound might influence the results of open trials.…”

Report on the Fourth Consensus Conference on the Methodology of Clinical Trials with Anxiolytic Drugs

“…Previous Consensus Conferences on the Methodology of Clinical Trials were held in 1988 in Zurich on Antidepressant Drugs (Angst et al, 1989), in 1989 in Munich on Nootropic Drugs (Amaducci et al, 1990) and in 1990 in Zurich on Neuroleptic Drugs (Angst et al, 1991).…”

Placebo response in schizophrenia: discussion

“…Nevertheless, the placebo-controlled trial remains the most efficient way to demonstrate efficacy of a new drug unequivocally (Angst et al, 1991). Moreover, the difference in drop-out rate lor inefficacy between placebo and the active drug is a powerful secondary efficacy parameter: in the same study (Chouinard et al, 1993) the drop-out rate in the placebo-group was 46% versus 5% for the risperidone 6 mg group.…”