In the Journals

Omega-3 fatty acids ineffective for psychosis in ultra-high risk adults

Omega-3 fatty acids were not effective for the prevention of psychosis, reduction of symptoms or improved functioning among adults at ultra-high risk for psychotic disorders, according to recent findings.

“Cognitive behavioral therapy has been found to be effective in many, although not all, of the published trials. However, the most striking result to date was the finding that ω-3 [polyunsaturated fatty acids] were superior to placebo in reducing the risk for transition to psychosis and psychiatric morbidity in general, not only during the period of treatment, but also for a subsequently prolonged time (median, 6.7 years),” Patrick D. McGorry, MD, PhD, of National Centre of Excellence in Youth Mental Health, Melbourne, and colleagues wrote. “Safe and beneficial to health in many ways, ω-3 [polyunsaturated fatty acids] represent a simple and relatively inexpensive potential treatment strategy.”

To replicate these findings, researchers conducted NEURAPRO, a double-blind, placebo-controlled randomized clinical trial among 304 adults with ultra-high risk for psychotic disorders across 10 specialized early psychosis treatment services. Study participants were randomly assigned to receive 1.4 g of ω-3 polyunsaturated fatty acids (n = 153) or placebo (n = 151) daily plus 20 sessions or fewer of cognitive behavioral case management over 6 months. The cohort had a mean age of 19.1 years.

At 6 months, 5.1% of the placebo group and 6.7% of the ω-3 polyunsaturated fatty acids group transitioned to psychosis.

Christoph U. Correll, MD
Christoph U. Correll

At 12 months, 11.2% of the placebo group and 11.5% of the ω-3 polyunsaturated fatty acids group transitioned to psychosis.

Transition rates did not significantly differ between groups (HR = 1.1; 95% CI, 0.55-2.23).

“Contrary to the earlier, smaller study, the results did not confirm the superior efficacy of ω-3 [polyunsaturated fatty acids] for the prevention of psychosis, reduction of symptoms, or improvement in functioning,” John M. Kane, MD, and Christoph U. Correll, MD, of Northwell Health System, Zucker Hillside Hospital, Glen Oaks, New York, wrote in an accompanying editorial. “One hopes that two additional multisite studies of ω-3 [polyunsaturated fatty acids] will further clarify its role in the prevention of psychosis. A nine-site consortium is in the final treatment phase of the North American Prodromal Longitudinal Omega-3 Fatty Acid vs. Placebo Study (projected sample, 128 participants) conducted in individuals aged 12 to 30 years at clinical risk for psychosis. The Placebo-Controlled Trial in Subjects at Ultra-High Risk for Psychosis with Omega-3 Fatty Acids in Europe will soon start in nine European Union countries (projected sample, 220 participants) in youth aged 13 to 20 years at risk for psychosis. Although the results from these trials will be important, they too select patients based only on clinical status without any additional inclusion criteria related to the expected target engagement of ω-3 [polyunsaturated fatty acids].” – by Amanda Oldt

Disclosure: McGorry reports receiving grant funding from National Alliance for Research on Schizophrenia and Depression; unrestricted research funding from AstraZeneca, Eli Lilly, Janssen-Cilag, Pfizer, and Novartis; honoraria for educational activities with AstraZeneca, Eli Lilly, Janssen-Cilag, Pfizer, Bristol-Myers Squibb, Roche, and the Lundbeck Institute. Kane reports receiving honoraria for lectures and/or consulting from Alkermes, Allergan, Bristol-Myers Squibb, Eli Lilly, Forrest Labs, Forum, Genentech, Intracellular Therapies, Janssen, Johnson & Johnson, LB Pharmaceutical, Lundbeck, Merck, Novartis, Neurocrine, Otsuka, Pfizer, Pierre Fabre, Reviva, Roche, and Sunovion; grant support from Genentech, Johnson & Johnson, and Otsuka; and serving as a shareholder of MedAvante, LB Pharmaceutical, and Vanguard Research Group. Please see the study for a full list of relevant financial disclosures.

Omega-3 fatty acids were not effective for the prevention of psychosis, reduction of symptoms or improved functioning among adults at ultra-high risk for psychotic disorders, according to recent findings.

“Cognitive behavioral therapy has been found to be effective in many, although not all, of the published trials. However, the most striking result to date was the finding that ω-3 [polyunsaturated fatty acids] were superior to placebo in reducing the risk for transition to psychosis and psychiatric morbidity in general, not only during the period of treatment, but also for a subsequently prolonged time (median, 6.7 years),” Patrick D. McGorry, MD, PhD, of National Centre of Excellence in Youth Mental Health, Melbourne, and colleagues wrote. “Safe and beneficial to health in many ways, ω-3 [polyunsaturated fatty acids] represent a simple and relatively inexpensive potential treatment strategy.”

To replicate these findings, researchers conducted NEURAPRO, a double-blind, placebo-controlled randomized clinical trial among 304 adults with ultra-high risk for psychotic disorders across 10 specialized early psychosis treatment services. Study participants were randomly assigned to receive 1.4 g of ω-3 polyunsaturated fatty acids (n = 153) or placebo (n = 151) daily plus 20 sessions or fewer of cognitive behavioral case management over 6 months. The cohort had a mean age of 19.1 years.

At 6 months, 5.1% of the placebo group and 6.7% of the ω-3 polyunsaturated fatty acids group transitioned to psychosis.

Christoph U. Correll, MD
Christoph U. Correll

At 12 months, 11.2% of the placebo group and 11.5% of the ω-3 polyunsaturated fatty acids group transitioned to psychosis.

Transition rates did not significantly differ between groups (HR = 1.1; 95% CI, 0.55-2.23).

“Contrary to the earlier, smaller study, the results did not confirm the superior efficacy of ω-3 [polyunsaturated fatty acids] for the prevention of psychosis, reduction of symptoms, or improvement in functioning,” John M. Kane, MD, and Christoph U. Correll, MD, of Northwell Health System, Zucker Hillside Hospital, Glen Oaks, New York, wrote in an accompanying editorial. “One hopes that two additional multisite studies of ω-3 [polyunsaturated fatty acids] will further clarify its role in the prevention of psychosis. A nine-site consortium is in the final treatment phase of the North American Prodromal Longitudinal Omega-3 Fatty Acid vs. Placebo Study (projected sample, 128 participants) conducted in individuals aged 12 to 30 years at clinical risk for psychosis. The Placebo-Controlled Trial in Subjects at Ultra-High Risk for Psychosis with Omega-3 Fatty Acids in Europe will soon start in nine European Union countries (projected sample, 220 participants) in youth aged 13 to 20 years at risk for psychosis. Although the results from these trials will be important, they too select patients based only on clinical status without any additional inclusion criteria related to the expected target engagement of ω-3 [polyunsaturated fatty acids].” – by Amanda Oldt

Disclosure: McGorry reports receiving grant funding from National Alliance for Research on Schizophrenia and Depression; unrestricted research funding from AstraZeneca, Eli Lilly, Janssen-Cilag, Pfizer, and Novartis; honoraria for educational activities with AstraZeneca, Eli Lilly, Janssen-Cilag, Pfizer, Bristol-Myers Squibb, Roche, and the Lundbeck Institute. Kane reports receiving honoraria for lectures and/or consulting from Alkermes, Allergan, Bristol-Myers Squibb, Eli Lilly, Forrest Labs, Forum, Genentech, Intracellular Therapies, Janssen, Johnson & Johnson, LB Pharmaceutical, Lundbeck, Merck, Novartis, Neurocrine, Otsuka, Pfizer, Pierre Fabre, Reviva, Roche, and Sunovion; grant support from Genentech, Johnson & Johnson, and Otsuka; and serving as a shareholder of MedAvante, LB Pharmaceutical, and Vanguard Research Group. Please see the study for a full list of relevant financial disclosures.