Participation in clinical trials may improve care of acute schizophrenia inpatients in a general hospital.

INTRODUCTION: This report demonstrates parameters of quality of care and treatment outcome of acute schizophrenia patients who were involved as subjects in a clinical trial of two marketed widely used antipsychotics compared with their fellow patients who received routine clinical hospital care. METHODS: Patients were newly admitted severely agitated schizophrenia patients who agreed to participate in a double-blind randomized trial of short-term (5 days) rate of improvement in response to two second-generation oral antipsychotics. Treatment outcomes as measured by the Clinical Global Impression and parameters of quality of care were compared with the general population of inpatients in the same county hospital. RESULTS: Of 145 patients screened, 109 patients did not meet study inclusion and exclusion criteria. It is of note that systematic diagnostic interview did not confirm the clinical diagnosis of schizophrenia in 17 patients (11.7%). Study patients had shorter length of stay (6.75 days vs 15.3 days of total psychiatric patients at the hospital during the study period), no physical restraints (vs 21.9%), no use of antipsychotics as chemical restraints (vs 19.8%), and less recidivism following the trial (28.1%) compared with prior to the trial (64.3%). CONCLUSION: Patients who participate in structured clinical research with well-delineated procedures, clinical outcome measures, and clear expectations, fared better than their fellow patients in the same non-research hospital wards. Application of some characteristics of clinical research to the diagnosis and treatment of clinical non-research patients may be considered.

Screening of patients for clinical trials of premenstrual syndrome/premenstrual dysphoric disorder: methodological issues.

For many clinical trials patients are first screened by telephone for inclusion and exclusion criteria. Initial screening procedures for women with premenstrual syndrome or premenstrual dysphoric disorder substantially affect the yield of subjects. It is also questionable whether the eventually selected women actually represent the general population of women with these disorders.