Randomized Double-Blind Trial of Omega 3 Fatty Acid Versus Placebo in Individuals at Risk for Psychosis

Recruitment of subjects for clinical assessment and testing with dependent measures is considered for research purposes. Use will be made of existing data and records as the data obtained from this protocol will be used in combination with all data and records collected as part of the overall NAPLS study in which subjects are already enrolled. Individuals for this protocol will be recruited from UCSD's parent NAPLS study.

Experimental Treatment: This will be a 24-week, randomized, double-blind, placebo, fixed dose-controlled study designed to determine the acceptability and feasibility of Omega-3FA versus placebo in prodromal subjects assigned to treatments on a 1:1 basis. Omega-3FA will be administered as oral capsules given twice daily (BID). Ocean Nutrition Canada will prepare identical-looking Omega-3FA and placebo capsules. The investigators will include 128 prodromal subjects in the 6-month trial. All subjects will receive monthly clinical assessment. The study design and Omega-3FA formulation are designed to be compatible with that of another on-going trial conducted by investigators in Australia and Europe (the Neuropro Study sponsored by the Stanley Foundation), which would enable the data from the two studies to be combined for analysis on the primary (conversion) and most of the secondary and tertiary (symptoms, functioning) endpoints.

The proposed study will potentially further the development of novel treatment approach for the prodrome of psychosis. This research will provide empirical data regarding a lower risk, broad spectrum treatment, which could have important implications for public health as a pre-emptive intervention or treatment augmentation because of the potential to effect functional outcome. It is possible that subjects in the treatment group will show an improvement in symptoms. Study participants will receive extensive clinical evaluations and consultation from investigators with knowledge regarding psychosis.

The results of this study will increase the ability to provide alternative treatments with potentially fewer side effects for the prodrome of psychosis. The potential implication for primary and tertiary prevention of psychosis from these treatments is immeasurable. Through the development and utilization of strategies such as those proposed in this research the investigators could potentially discover the ability to delay the onset of psychosis and manage treatment more effectively with fewer side effects seen with traditional antipsychotic medication treatment. The importance of this to public health would be tremendous.

The use of Omega-3FA in an adolescent and young adult prodromal population is somewhat novel. Amminger et al 60 utilized a sample of 13 - 25 year old prodromal subjects to determine the potential benefit of EPA and DHA. Previous studies using Omega-3FA in adolescent and adult samples of psychotic subjects have produced no significant side effects. Some subjects reported a fishy aftertaste and mild gastrointestinal difficulties that dissipated with the discontinuation of Omega-3FA. Therefore the level of risk is considered minimal. This study offers subjects the possibility of direct benefit from participation because of the Omega-3FA and placebo treatments. It is also possible that the concurrent use of Omega-3FA will improve metabolic indices in all subjects. Because Omega-3FA is not specifically approved by the FDA for use in early psychosis, the investigators have received a certificate for an Investigational New Drug (IND) for the current Research Plan.