NAPLS Omega-3 Fatty Acid Versus Placebo Study

Summary

The overall goal of the present study is to determine whether Omega-3 Fatty Acids potentially prevent onset of psychosis and improve clinical symptoms and functional outcome in youth and young adults at elevated clinical risk for schizophrenia and related disorders. The specific aims are: (1) To determine whether the rate of progression to psychosis is lower during six months of treatment with Omega-3 Fatty Acids compared to six months of treatment with placebo, (2) To determine whether Omega-3 Fatty Acids are more efficacious than placebo for prodromal symptoms, negative symptoms, and functioning, (3) To assess the safety and tolerability of Omega-3 Fatty Acids in this population, and (4) To conduct analyses of neuroimaging, neurocognitive, electrophysiological and other ancillary data to explore mechanistic explanations for the hypothesized benefits of Omega-3 Fatty Acids on clinical and functional outcomes (e.g., increases in white matter integrity and processing speed).

Timeline

Start

2011-08

Primary completion

2016-06

Completion

2016-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Omega 3 Fatty Acid vs Placebo; p = .51; Cox Proportional Hazard .36; Chi-squared NCT01429454 ↗

Drugs

Indications