CONTENT AND QUALITY OF 2000 CONTROLLED TRIALS IN SCHIZOPHRENIA OVER 50 YEARS

Objective To provide a comprehensive survey of the content and quality of intervention studies relevant to the treatment of schizophrenia. D esign Data were extracted from 2000 trials on the Cochrane Schizophren ia Group's register. Main outcome measures Type and date of publicatio n, country of origin, language, size of study, treatment setting, part icipant group, interventions, outcomes, and quality of study. Results Hospital based drug trials undertaken in the United States were domina nt in the sample (54%). Generally, studies were short (54% < 6 weeks), small (mean number of patients 65), and poorly reported (64% had a qu ality score of less than or equal to 2 (maximum score 5)). Over 600 di fferent interventions were studied in these trials, and 640 different rating scales were used to measure outcome. Conclusions Half a century of studies of limited quality, duration, and clinical utility leave m uch scope for well planned, conducted, and reported trials. The drug r egulatory authorities should stipulate that the results of both explan atory and pragmatic trials are necessary before a compound is given a licence for everyday use.