Considerations For Future Intervention Trials

The long history of clinical studies in cardiovascular diseases, infant nutrition, and other illnesses have yielded valuable lessons that can help to form the design of future studies of psychiatric disorders. Baseline measurements are essential, as some subjects may enter the study with high tissue concentrations of EPA and DHA and supplementation may produce little additional effect. Biological markers are the most accurate measure of fatty acid status, but a simple dietary questionnaire may be able to screen out subjects with a high omega-3 intake. The baseline diet should be standardized at a low seafood and omega-3 intake. If subjects in the placebo group begin to eat more fish because of their excitement in being part of the study, then treatment effects may be difficult to detect. Consideration should be given to the course of their illness and number of failed treatments. For example, it may be difficult to detect treatment differences among subjects who are treatment resistant and have failed all other therapies. Sample sizes should be calculated differently for prevention and treatment studies. Unfortunately, it is currently unknown what length of treatment will be required to change brain fatty acid composition among psychiatric subjects. It is also unknown what time period is required to observe a clinical effect after a change in tissue composition is achieved. The use of placebos and comparison oils should also be carefully considered. Flavor masking should be considered with the addition of small amounts of fish oils or other flavors to placebo oils. If possible, compounds should be balanced for their degree of unsaturation, delivery form (i.e., triglycerides or ethyl esters or phospholipids), and their caloric content. A positive placebo control may be useful when omega-3 fatty acids are to be compared to other psychotrophic agents that have sexual or other side effects. Study subjects should always be asked if they can identify their treatment group and these data reported. Whenever possible, plasma or red blood cell analyses should be used to confirm treatment and dietary compliance.

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