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Forty years of antidepressant drug trials

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Objective: This study was conducted to investigate whether the quality of antidepressant drug trials has improved during the last 40 years.

Method: A sample of 314 randomized clinical trials published between 1962 and 1998 was analysed.

Results: From 1962 to 1970 the median number of patients per trial was 56 (range 24–137), from 1971 to 1980 was 50 (10–211) and from 1981 to 1990 was 51 (20–314). In the last 8 years the median sample size increased to 100 patients (20–1002). Trials had a median duration of 4 weeks in the first two decades of publication, and a median duration of 6 weeks in the following two decades. Patient selection criteria have become increasingly sophisticated and the median number of efficacy measures increased in the last 4 decades from 1 to 4.

Conclusion: Stringent selection criteria and sophisticated outcome assessment tend to exclude typical patients from randomized controlled trials and made it more difficult to follow many patients in the long term.

Keywords: antidepressant drugs; randomized clinical trial; systematic review

Document Type: Research Article

Affiliations: 1: Department of Psychological Medicine, Institute of Psychiatry, De Crespigny Park, London and Istituto di Ricerche Farmacologiche ‘Mario Negri’ Milan, and Dipartimento di Medicina e Sanità Pubblica, Sezione di Psichiatria, Università di Verona, Italy and 2: Department of Psychological Medicine, Guy's, King's and St Thomas' School of Medicine, 103 Denmark Hill, London, UK

Publication date: 2001-08-01

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