Methodological Problems of Prophylactic Trials in Recurrent Affective Disorders

Designs used with success in therapeutic experiments are not necessarily suited to prophylactic trials, which offer special problems and require that new experimental procedures and statistical methods are employed.

Controlled prophylactic trials may be carried out in two different ways: (i) Concurrent comparison of the course of the disease in an experimental patient group and a control group, and (ii) studies on a single group of patients during successive control periods and drug periods. Each procedure offers advantages and disadvantages; ethical problems are of particular importance.

Special attention should be given to the definition of patient samples and to the criteria chosen for recording a relapse. Experiments must be designed with consideration of the role played by non-pharmacological factors: spontaneous variation of the disease course during treatment, the psychological effects of the treatment, and observer bias.

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