Comparing the efficacy of atypical antipsychotics in open uncontrolled versus double-blind controlled trials in schizophrenia.
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Comparing the efficacy of atypical antipsychotics in open uncontrolled versus double-blind controlled trials in schizophrenia. / Pajonk, Frank-Gerald; Holzbach, Rüdiger; Naber, Dieter.
in: PSYCHOPHARMACOLOGY, Jahrgang 162, Nr. 1, 1, 2002, S. 29-36.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Comparing the efficacy of atypical antipsychotics in open uncontrolled versus double-blind controlled trials in schizophrenia.
AU - Pajonk, Frank-Gerald
AU - Holzbach, Rüdiger
AU - Naber, Dieter
PY - 2002
Y1 - 2002
N2 - OBJECTIVE: Due to methodological reservations, open clinical trials investigating efficacy and tolerability of antipsychotic agents are often regarded with doubt. However, there are nearly no studies comparing findings of controlled double-blind with those of open trials. The aim of this study was to investigate whether results of open and double-blind approaches differ and thereby gain information about the validity of open trials. METHODS: After literature research, three atypical antipsychotic agents were identified for which at least three open and double-blind trials existed that met the inclusion criteria and from which either the reduction of the Brief Psychiatric Rating Scale (BPRS)- or Positive and Negative Symptom Scale (PANSS) scores or the response rate could be determined. RESULTS: There were no differences in the reduction of the BPRS- or PANSS scores or in the response rates for all three antipsychotic agents between open and double-blind trials. CONCLUSIONS: 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.
AB - OBJECTIVE: Due to methodological reservations, open clinical trials investigating efficacy and tolerability of antipsychotic agents are often regarded with doubt. However, there are nearly no studies comparing findings of controlled double-blind with those of open trials. The aim of this study was to investigate whether results of open and double-blind approaches differ and thereby gain information about the validity of open trials. METHODS: After literature research, three atypical antipsychotic agents were identified for which at least three open and double-blind trials existed that met the inclusion criteria and from which either the reduction of the Brief Psychiatric Rating Scale (BPRS)- or Positive and Negative Symptom Scale (PANSS) scores or the response rate could be determined. RESULTS: There were no differences in the reduction of the BPRS- or PANSS scores or in the response rates for all three antipsychotic agents between open and double-blind trials. CONCLUSIONS: 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.
M3 - SCORING: Zeitschriftenaufsatz
VL - 162
SP - 29
EP - 36
JO - PSYCHOPHARMACOLOGY
JF - PSYCHOPHARMACOLOGY
SN - 0033-3158
IS - 1
M1 - 1
ER -
