Attitudes of patients with schizophrenia toward placebo-controlled clinical trials.
BACKGROUND
Despite the fact that the efficacy of antipsychotic treatment in patients with schizophrenia has been demonstrated in numerous double-blind studies, placebo-controlled studies are still commonly performed. Although much is known about the opinions of professionals concerning this issue, so far nothing is known about the opinions of patients who are most affected by the realization of placebo-controlled clinical trials.


METHODS
In a cross-sectional study from June 2000 to January 2001, 100 inpatients and outpatients with ICD-10 schizophrenia or schizophreniform disorder were investigated by using a questionnaire specifically developed to survey patients' attitudes concerning possible participation in placebo-controlled clinical trials. Psychopathology and side effects were physician-rated.


RESULTS
56% of patients would not be willing to participate in a placebo-controlled clinical trial. On the other hand, only about 16% of the patients are against clinical trials in principle. Gender, treatment, severity of psychopathology (Positive and Negative Syndrome Scale), adverse events (UKU Side Effect Rating Scale), and attitude toward medication (Drug Attitude Inventory) had no statistically significant influence on the decision. Most of the patients (76%) stated that they would not lose trust in their physician if asked to participate in a placebo-controlled clinical trial.


CONCLUSIONS
The opinions and fears of patients who are most affected by the debate need to be considered when deciding whether a placebo-controlled clinical trial is necessary.
Hummer
Martina
M
Department of Biological Psychiatry, Innsbruck University Clinics, Innsbruck, Austria. martina.hummer@uibk.ac.at
Holzmeister
Roswitha
R
Kemmler
Georg
G
Eder
Ursula
U
Hofer
Alex
A
Kurzthaler
Ilsemarie
I
Oehl
Maria
M
Weiss
Elisabeth
E
Fleischhacker
W Wolfgang
WW
D000328:Adult; D000553:Ambulatory Care; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001294:Attitude to Health; D018849:Controlled Clinical Trials as Topic / Q000523:psychology*; D003430:Cross-Sectional Studies; D003657:Decision Making; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D010358:Patient Participation / Q000523:psychology*; D018579:Patient Selection; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D011618:Psychotic Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D012565:Schizophrenic Psychology
D014150:Antipsychotic Agents; D010919:Placebos