Let the replications roll of Omega-3 in 50 states in the next 12 months to prevent First-Episode Psychosis

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In November 2014, NIMH Director Insell wrote: “Each year, about 500,000 young people in this country seek help for symptoms that resemble the prodrome of a psychotic illness. They are not actively psychotic, but they may be struggling in school, dealing with odd thoughts, and becoming socially isolated. Some describe brief hallucinations or paranoid ideas. Many have become “basement kids,” playing video games alone most of the week and losing interest in the world above ground. Most of these youth will, ultimately, be fine. But about one in three of those identified as high risk will have a first psychotic episode within three years.”

The Pressing Problem
Over the next seven years, that would be about 3,500,000 young people with those symptoms, and about 1,200,000—1,400,000 who may convert to full-blown psychosis—if the history of science repeats. Imagine the suffering, the loss of freedom, the pain and losses for those individuals, their families and friends, and society in general. Some proportion of those future events will replay past headlines of episodes of first episode psychoses: Tucson, Aurora, Newtown and more.

The Promise of Protection and Prevention
Hope is real about a simple proven treatment [1] that followed young people for seven years. These results are not the fake hope that more early, unspecified or generic treatment will help. Theoretically, the randomized-control, longitudinal study on omega-3 fatty acid might avert a million cases of first episode psychosis, if these benefits are replicable.

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Harnessing the Urge to Use Omega 3 for Rapid Proof
Replications are everything in science. Temperate souls urge caution about this finding, but not desperate families and their doctors. If you were the family, the individual, or the doctor, would you want to wait seven years for Amminger’s new and larger replication in process [2] to try omega 3? Probably not, as a rational human [3].

Why is it rational? The risk is low based on a consensus recommendation by an American Psychiatric Association panel that all persons with psychiatric diagnoses should have at least 1 gram per day of high-quality omega 3 [4], and for God’s sake the Pentagon is testing omega-3 to reduce suicides and PTSD among military service members [5]. There will be a riot of use of omega-3 by families, doctors and individuals; it’s something they can do when the situations looks otherwise hopeless. With no significant adverse effects documented [6], there is nothing much to loose by trying omega 3.

Telling people not to use omega-3 until some distant replication happens will work about as well as telling people not to flee war-torn Syria. How is that working?

We can and should harness what will obviously happen to achieve rapid, replicated planned variation studies to avert first episode psychosis. It can be a modern equivalent taking the equivalent of the promising antibody results of the Salk vaccine in 1954 [7] to scale in 1955 with the massive mobilization of Thomas Francis study that actually proved it was possible to prevent polio cases and deaths among children rapidly [8]. We can mobilize every state, the District of Columbia, our territories, and our Federally Recognized Tribes to test planned variations of placebo, omega-3 and third condition designed to enhance protective effects.

A Plan for Testing Rapid Episode Psychosis Prevention Strategies
Some 60 diverse sites would be funded, to test three different conditions: a) a dose of omega-3, preferably variations across sites to find the optimum dose-response; b) an alternative active condition or augmentation of omega-3 such as acceptance and commitment therapy (ACT) strategy that averted relapse from psychosis [9] or the “prize bowl” contingency management system to reduce addictions and improve adherence to treatment [10] or some previously tested family support system like Community Reinforcement and Family Training (CRAFT) [11, 12]; and c)  placebo control. Forty to sixty people per condition per state/location would likely be sufficient, because of the ability to pool data for meta-analyses. Each site would collect the same physiological and genetic data, informed by subsequent analyses from continuing experiments on omega-3 [2, 13, 14]. To measure medical compliance, both the active omega-3 and placebo would have riboflavin added, as a UV light will give the patients’ urine an eerie purple glow [15, 16]. There are research groups in every state that can do this type of study.

The Prize? Potential Population-Level Prevention of First-Episode Psychosis
With a year’s data from each site, we’d have a very good idea of how to avert the scourge of first episode psychosis with a sample of approximately 7,000 people—about the same sample size of Jonas Salk’s breakthrough study polio prevention study in 1954 [7]. After Salk’s breakthrough and the findings of the massive effort headed by Thomas Francis [8] in 1955, the prevalence of cases of polio fell from 28,000 to just 168 in 1963, the year of Kennedy’s assassination. We have almost as good science to significantly avert or reduce psychoses and other mental illnesses with omega-3 today. We can talk and whine, or we can be bold like the Thomas Francis led effort. The public pushed the demand to prevent polio, using dimes from kids, dollars from adults and thousands from organizations. We did it, and my generation and subsequent generations were protected from polio.

Who stands to protect our young people from the tragedy of first-psychosis? Certainly we can raise the $300K to $500k to test the planned variations in every jurisdiction. There are families, organizations and companies who have such resources in every major community of America who’ve been touched by first-episode psychosis. Let’s not stall. All of us in America have stake and role to bankroll the prevention of first-episode psychosis. Let’s roll.

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Dennis Embry, President/Senior Scientist at PAXIS Institute – Dennis D. Embry is a prominent prevention scientist in the United States and Canada, trained as clinician and developmental and child psychologist. He is president/senior scientist at PAXIS Institute in Tucson and co-investigator at Johns Hopkins University and the Manitoba Centre for Health Policy. His work and that of colleagues cited in 2009 the Institute of Medicine Report on The Prevention of Mental, Emotional, and Behavioral Disorders Among Young People. Clinically his work has focused on children and adults with serious mental illnesses. He was responsible for drafting of the letter signed by  23 scientists, who collectively represent scores of randomized prevention trials of mental illnesses published in leading scientific journals. In March 2014, his work and the work of several signatories was featured in a Prime-TV special on the Canadian Broadcast Corporation on the prevention of mental illnesses among children—which have become epidemic in North America. Dr. Embry serves on the Children's Mental Health Network Advisory Council.

Neither Dr. Embry nor PAXIS Institute receive any funding or compensation from the manufactures or manufacture’s associations of omega-3 fatty acid preparations or pharmaceutical products, nor sell such products. Neither Dr. Embry nor PAXIS Institute derive any income from such products. Dr. Embry does take two full grams of omega-3 per day (more EPA over DHA), as suggested by multiple studies originating from the U.S. National Institutes of Health.


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References

1. Amminger, G.P., et al., Longer-term outcome in the prevention of psychotic disorders by the Vienna omega-3 study. Nat Commun, 2015. 6: p. 7934.

2. Markulev, C., et al., NEURAPRO-E study protocol: a multicentre randomized controlled trial of omega-3 fatty acids and cognitive-behavioural case management for patients at ultra high risk of schizophrenia and other psychotic disorders. Early Interv Psychiatry, 2015.

3. Solis, M., Prevention: Before the break. Nature, 2014. 508(7494): p. S12-3.

4. Freeman, M.P., et al., Omega-3 fatty acids: evidence basis for treatment and future research in psychiatry. Journal of Clinical Psychiatry, 2006. 67(12): p. 1954-67.

5. Lewis, M.D. and J. Bailes, Neuroprotection for the warrior: dietary supplementation with omega-3 fatty acids. Mil Med, 2011. 176(10): p. 1120-7.

6. Schlogelhofer, M., et al., Polyunsaturated fatty acids in emerging psychosis: a safer alternative? Early Interv Psychiatry, 2014. 8(3): p. 199-208.

7. Salk, J.E., et al., Studies in human subjects on active immunization against poliomyelitis. II. A practical means for inducing and maintaining antibody formation. Am J Public Health Nations Health, 1954. 44(8): p. 994-1009.

8. Francis, T., Jr., et al., An evaluation of the 1954 poliomyelitis vaccine trials. Am J Public Health Nations Health, 1955. 45(5 Pt 2): p. 1-63.

9. Bach, P., S.C. Hayes, and R. Gallop, Long-Term Effects of Brief Acceptance and Commitment Therapy for Psychosis. Behav Modif, 2011.

10. Petry, N.M., Contingency management for substance abuse treatment: A guide to implementing evidence-based practice. 2012: New York, NY, US: Routledge/Taylor & Francis Group. xiii, 320.

11. Meyers, R.J., et al., Community reinforcement approaches: CRA and CRAFT, in Interventions for addiction: Comprehensive addictive behaviors and disorders (Vol 3), P.M. Miller, et al., Editors. 2013, Elsevier Academic Press: San Diego, CA, US. p. 47-56.

12. Meyers, R.J., H.G. Roozen, and J.E. Smith, The community reinforcement approach: An update of the evidence. Alcohol Research & Health, 2011. 33(4): p. 380-388.

13. Lavoie, S., et al., Correlates of electroencephalographic resting states and erythrocyte membrane docosahexaenoic and eicosapentaenoic acid levels in individuals at ultra-high risk of psychosis. Aust N Z J Psychiatry, 2015.

14. Amminger, G.P., et al., Predictors of treatment response in young people at ultra-high risk for psychosis who received long-chain omega-3 fatty acids. Transl Psychiatry, 2015. 5: p. e495.

15. Dubbert, P.M., et al., Riboflavin as a tracer of medication compliance. J Behav Med, 1985. 8(3): p. 287-99.

16. Del Boca, F.K., et al., Assessment of medication compliance in alcoholics through UV light detection of a riboflavin tracer. Alcohol Clin Exp Res, 1996. 20(8): p. 1412-7.



Comments

  1. Dennis Embry's avatar
    Dennis Embry
    | Permalink
    Dr. Jorm, My apologies you work with the Melbourne folks Yeah for you. This is why I proposed the 50 state study, because there are huge differences in the US on background intake of n6 compared to n3. The ratio differences have a significant impact, according to the work of Joe Hibbeln at NIH in the US. There are some really cool studies in process here in the US with military service members, altering the dietary intake of n3 and n6. As you almost certainly know, there is also a significant relationship between skin color, latitude and schizophrenia—moderated by fish intake. That suggests d3 as variable.

    Do you know in the larger study if they sampled gene x treatment inaction? Dennis
  2. Dennis Embry's avatar
    Dennis Embry
    | Permalink
    Thank you for the notice for the larger study. It has not be published or available. I cannot review or comment. Non replications happen on almost everything, as anyone knows who does good science.That per se does not say it does not work. Many medications don't work in larger studies, and this may be for many reasons. I look forward to reading the study, and perhaps you can send me the poster. This could also be a gene x treatment interaction or something related to n6 consumption in this larger sample. These kind of studies are most helpful.
  3. Anthony Jorm's avatar
    Anthony Jorm
    | Permalink
    Unfortunately, the findings of Amminger et al in the Vienna study were not replicated in the much larger Neurapro-E study, which involved over 300 participants. According to a poster by McGorry and colleagues presented at 15th International Congress on Schizophrenia Research (The BroadMoor, Colorado Springs, Colorado, USA, 28 March - 1 April 2015), the 12-month transition rate was 11.5% for omega-3 fatty acids compared to 11.2% for placebo. According to the poster: “The intention-to-treat Kaplan-Meier survival analysis indicated no significant differences in the rate of transition to psychosis (primary outcome) between the groups who received fish oil or placebo capsules at the 12-month follow-up.”
  4. Dennis Embry's avatar
    Dennis Embry
    | Permalink
    George that is a great question. It's a little tricky question, because the intake of omega-6 is much higher in the US than other countries. Omega 6 worsens mental health symptoms. See NIH study here: http://www.ncbi.nlm.nih.gov/pubmed/?term=healthy intakes hibbeln

    Ammingers' study was done outside the US. My rough guess in the US is about 2.5 to 3 grams of high-quality 2-to-1 EPA over DHA. If it were my kid, I'd decrease omega-6 in their diet, too. All that requires a longer essay.
  5. George Patrin, MD, MHA's avatar
    George Patrin, MD, MHA
    | Permalink
    Dennis,

    I am both a "desperate (family member) and ...doctor." I do not want to wait for more replication studies to try omega 3. As a "rational human" I would like to follow the recommendation that all persons with psychiatric diagnoses, or risk of same (I.e. have first or second order relatives with psychotic disorder) starting at 20 years old, should have at least 1 gram per day of high-quality omega 3 [4] per day. Does this also make sense, regardless of whether the States join together to conduct this replication study?
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