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Fish Oils in Mental Illness(predominantly)

63 posts in this topic

I am trying to do an audit on fish oils in our hospital & so was trying to find out the standards.

I have looked at the Cochrane review(there is one), Taken info and references from Maudsley guidelines 2005-2006, Psychotropic drug directory 2006,Medilne,Nice,SIGN, DoH Website,Wikipedia & lot of patient information sites etc.....

Here is the info:- (May be it will take more than 1 post to put it all in)


Fish oil is oil derived from the tissues of oily fish. This oil naturally contains the Omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Fish oil is now recommended for a healthy diet. It is beneficial to eat fish once a week (or more) but care must be taken to avoid the fish species which contain the toxin mercury or other contaminants such as Chlordane. The list of fish includes: Largemouth Bass, Sturgeon, and others such as Shark, Swordfish, King mackerel, and Tilefish. Note that these species are often predators, which can accumulate toxic substances due to their position at the top of the food chain.

Benefits of fish oil

Some experts believe that taking fish oil (in any form) can help regulate cholesterol in the body. This is because of the high levels of Omega 3, specifically the effects of the EPA and DHA constituents on Peroxisome proliferator-activated receptor alpha (PPAR[ch945]), whose benefits include not only reduction of cholesterol, but also anti-inflammatory properties and positive effects on body composition. However, the preferred source of Omega 3 should be from the fish's body, not the liver. The liver of fish and many animals, such as seals and whales, contains, besides Omega-3, the active form of Vitamin A, such as in cod liver oil. At high levels, this form of the vitamin can be dangerous. This proved fatal to early explorers to the land of the Inuit. They were given raw liver by the natives, which contained a toxic overdose of Vitamin A for the white explorers; however, the same amount was harmless to the Inuit, who had no other source of Vitamin A except animal livers.

Some studies[1] were conducted on prisoners in England where the inmates were fed seafood which contains Omega Three Fatty acids. It was observed that the high consumption of these fatty acids led to a drop in the homicide rates. Another study was conducted in Finland where they found that prisoners who were convicted of violence had lower levels of Omega Three Fatty Acids than normal. It was suggested that these kinds of fatty acids are responsible for the neuronal growth of the frontal cortex of the brain which in turn is responsible for the personal behavior.

The American Heart Association recommends the consumption of 1g of fish oil daily, preferably by eating fish, for patients with coronary heart disease.[2]

The US National Institute of Health lists three conditions for which fish oil and other omega-3 sources are most highly recommended (Grade A scientific evidence): Hypertriglyceridemia, Secondary cardiovascular disease prevention and High blood pressure. It then lists 27 other conditions for which there is B or C grade evidence. It also lists possible safety concerns: 'Intake of 3 grams per day or greater of omega-3 fatty acids may increase the risk of bleeding, although there is little evidence of significant bleeding risk at lower doses (245-247). Very large intakes of fish oil/omega-3 fatty acids ('Eskimo' amounts) may increase the risk of hemorrhagic (bleeding) stroke.' (NIH Medline Plus)

According to a study from Louisiana State University in September 2005, fish oil may help protect the brain from cognitive problems associated with Alzheimer's disease.[3]

A study from the University of Adelaide [4] indicated that fish oil may be as or more effective than Ritalin for treating Attention-deficit hyperactivity disorder.

For purchasing fish oil dietary supplements, it is often recommended to seek a label certifying the product to be distilled, pharmaceutical grade, and free of mercury and other toxins.

Psychiatrist Tim Crow has argued that schizophrenia may be the evolutionary price we pay for a left brain hemisphere specialization for language.56 Since psychosis is associated with greater levels of right brain hemisphere activation and a reduction in the usual left brain hemisphere dominance, our language abilities may have evolved at the cost of causing schizophrenia when this system breaks down.

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Acta Psychiatr Scand. 2000 Jul;102(1):3-11.

Related Articles, Links

Are fish oils an effective therapy in mental illness--an analysis of the data.

Maidment ID.

Hellesdon Hospital, Norwich, Norfolk, UK.

OBJECTIVE: To review the literature regarding the use of fish oils in the treatment of psychiatric illness. METHOD: A Medline search was conducted in September 1999. RESULTS: Five papers have investigated omega-3 fatty acids levels in depression. One study used omega-3 fatty acids as an adjunctive therapy in bipolar disorder. Four studies used fatty acids as an adjunctive therapy in schizophrenia. CONCLUSION: There is a great deal of current research in this field. While omega-3 fatty acids levels may be lowered in depression, there are no data suggesting that omega-3 fatty acids are effective. One paper indicates that omega-3 fatty acids are effective in bipolar disorders. The data on schizophrenia are conflicting. Omega-3 and omega-6 fatty acids have proved effective. Most of the evidence suggests that the main effect is an improvement in negative symptoms. One recent study showed that omega-3 fatty acids had no effect on negative symptoms.

Publication Types:

• Review

PMID: 10892603 [PubMed - indexed for MEDLINE]


Omega-3 Fatty Acids and Mental Health: Is It Just A Fish Tale?

by Amy Scholten, MPH

In recent years, you’ve probably heard health experts extolling the potential cardiovascular benefits of eating more omega-3 fatty acids—fats found in fish and certain plant foods. Increasing evidence suggests that omega-3 fatty acids may also be beneficial for the prevention and treatment of certain mental disorders, particularly depression.

Omega-3’s: From the Land and the Seas

Omega-3 fatty acids, a type of polyunsaturated fat, are considered “good fats.” Omega-3 refers to their chemical structure. There are three types of omega-3 fatty acids: docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and alpha-linolenic acid (ALA).

The following foods contain omega-3 fatty acids:

• Fatty fish, including:

o Salmon

o Mackerel

o Tuna

o Herring

o Halibut

• Plant foods, such as:

o Ground flaxseed

o Flaxseed oil

o Canola oil

o Soybean oil

o Walnuts

o Leafy greens

o Tofu

Many health experts believe that omega-3 fatty acids may be crucial for brain function and that a deficiency could lead to or exacerbate mental illness in certain people.

Researchers “Fish” for Evidence


Depression has become increasingly prevalent in Western society. Some researchers believe that this may, in part, be due to major dietary changes that have occurred during the past century, which have resulted in a decreased consumption of omega-3 fatty acids. Several studies suggest that omega-3 fatty acids may be beneficial in the treatment of depression.

Omega-3 Levels in Diet and Red Blood Cell Membranes of Depressed Patients

A study published in the March 1998 issue of the Journal of Affective Disorders found low levels of omega-3 polyunsaturated fatty acids in the red blood cell (RBC) membranes of depressed patients but not in a well-matched healthy control group. The study also found that increasing severity of depression was related to decreasing RBC membrane levels of omega-3 fatty acids as well as decreasing dietary intake of omega-3 fatty acids.

Fish Consumption and Depression

In the April 1998 issue of The Lancet, Dr. Joseph Hibbeln, a researcher at the National Institute on Alcohol Abuse and Alcohol Consumption, reviewed data from nine countries and found a high incidence of depression in countries with low fish consumption. He cautioned that various economic, social, cultural and other factors could have influenced the results of the study. However, additional studies have found that high blood plasma concentrations of docosahexaenoic acid, an omega-3 fatty acid found in fish, have been linked to increased serotonin turnover and lower incidences of depression and suicide.

Fat-Restricting Diets and Depression

In the April 2000 issue of Nutrition Reviews, researchers reviewed a number of studies that suggest that there may be an association between extremely low-fat diets, low cholesterol levels, and an increase in the incidence of depression.

Included in the review was an observation by researchers at the University of Arizona that fat restriction and cholesterol-lowering drugs may change concentrations of polyunsaturated fatty acids in the tissues, including nerve tissue. Fat-restricting diets tend to lead to an increased intake of omega-6 polyunsaturated fatty acids and a relative decrease in the intake of omega-3 fatty acids. For certain people, these changes might increase the risk of depression.

The review included other large-scale studies that demonstrated a clear association between low blood levels of omega-3 fatty acids and an increased risk of depression, violence, and suicide.

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All EBSCO Publishing proprietary, consumer health and medical information found on this site is accredited by URAC. URAC's Health Web Site Accreditation Program requires compliance with 53 rigorous standards of quality and accountability, verified by independent audits.


Page 69-70 (Fish Oils in Schizophrenia)

These compounds are thought to be involved in maintaining neuronal membrane structure, in the modulation of membrane proteins & in the production of Prostaglandins & Leucotrienes((Fenton WS, Hibbeln J , Knable M Fatty Acids in Schizophrenia Biological Psychiatry 2000;47:821 )

They have ben suggested as treatments for a variety of psychiatric illnesses (Freeman MP, Omega 3 Fatty Acids in Psychiatry; a review.Ann Clin Psychiatry 2000; 12:159-165).

But most research relates to their use in Schizophrenia where case reports( RichardsonAJ, Easton T, Puri BK Red cell &Plasma fatty acid changes accompanying symptom remission in a patient with Schizophrenia treated with eicosapentanoic acid. Eur Psychopharmacology 2000; 10: 189-193, Puri BK , Richardson AJ, Horrobin DF etal eicosapentanoic acid treatment in schizophrenia associated with symptom remission,normalization of blood fatty acids,reduced neuronal membrane phospholipids turnover a nd structural brain changesInt J Clin Pract 2000;54:57-63, Su K-P, Shen W, Huang S-Y Omega 3 fatty acids as a psychotherapeutic agent for a pregnant schizophrenic patient Eur Neuropsychopharm 2001;11:295-299)

And Prospective trials suggest useful efficacy

Mellor etal 1995 20 pts, open label evaluation of fish oil added to usual medication, significant improvement in symptoms

Peet etal 2001 45 pts, &nbsp:lol:ouble blind, placebo controlled RCT at 2Gms daily for 12 months, EPA significantly more effective than DHA or placebo.

Peet and Horrobin 2002 115 pts, double blind RCT of ethyl EPA(1,2 or 4 gms/day) and placebo added to antipsychotic treatment(placebo, conventional or atypicals or clozapine) for 12 weeks, Ethyl EPA significantly improved response in patients receiving clozapine, 2Gms/day most effective dose

And tolerability

Emsley etal 2002, 40pts , Double Blind RCT of EPA(3g daily) and placebo added to standard drug treatment for 12 week, EPA associated with significant reduction in symptoms and tardive dyskinesia(9 patients in each group received clozapine)

“ on balance current evidence suggests that EPA(2-3 g daily) is a worthwhile option in schizophrenia when added to standard treatment particularly clozapine”


Joy CB, Mumbry-croft R, R JoyLA Polyunsaturated fatty acid supplementation for Schizophrenia, the Cochrane Database of Systemtatic Reviews 2003; issue

However doubt still remain over the true extent of the beneficial effect derived from fish oils.

Fish oils are relatively cheap, well tolerated(Mild GI symptoms can occur) and may benefit physical health.

“Fish oils are therefore very tentatively recommended for the treatment of residual symptoms of Schizophrenia but particularly in patients responding poorly to clozapine. Careful assessment of response is essential & fish oils should be withdrawn if no effect after 3 months treatment.”


Page 153

EPA 1-2 g/day, developing database.Usually added to antidepressant treatment

Peet M , Horrobin D, A dose ranging study of the effects of Ethyl EPA in patients with ongoing depression despite apparently adequate treatment with standard drugs, Arch Gen Psychiatry 2002;59:913-919

Su KP, Huang SY, Chiu CC, etal Omega 3 fatty acids in major depressive disorder a preliminary double blind placebo controlled trial Eur Neuropsychopharm 2003; 13:267-271

Nemets B, Stahl Z, Belmaker RH, Addition of Omega 3 fatty acid to maintainance medication treatment for recurrent unipolar depressive disorder,Am J Psychiatry 2002;159: 477-479

“ No mention of fish oils either in NICE or SIGN !”

No advise regarding fish oils on the Dept of Health website as on Aug 06

(Patient leaflet on fish oils)

The Royal College of Psychiatrists website has on search got 1 hit(for Alzheimer’s disease!)

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UKPPG Message Boards :-

I understand Boots withdrew their Fish Oil capsules recently because of

high dioxin levels. I have also found that most other brands have a lower

EPA content, including Omacor.

My understanding is that as Fish Oils are being used as part of the treatment for mental disorder, then they should be included on the Form 39. Our RMO’s do tend to include them if they are being used in doses recommended for schizophrenia, but not if they are being used as a dietary supplement to improve mental health (if that makes sense)

We've used fish oils in the form of Maxepa capsules (x5 BD) on just a

handful of occasions. We've only really tried them in situations of

desperation with chronic schizophrenia when all else has failed. We haven't

used them with any great hopes of success, but more to allow us to feel we

have tried absolutely every option. I don't think we've had any major

success, and have reviewed it as suggested. One patient was keen to continue

even though it had no benefit on his mental state. However, we felt that it

was unlikely to be doing him any harm, so we allowed him to continue.


Reaside Clinic,

We tend to recommend the omega-3 compounds licensed to

reduce triglyceride levels e.g. Omega-3-acid ethyl esters

(Omacor) as you suggest , or Omega-3-acid-marine

triglyceride (Maxepa).

As you mentioned the EPA content is less than MorEPA,

however, when I reviewed the evidence (what weak evidence

there was in 2000 Acta Psych Scand 102:3-11) there was no

evidence that EPA treated depression. The conclusion of the

review was that while omega-3 FA levels may be lowered in

depression, there are no data suggesting omega-3 FA are


A number of studies have been published since this review -

the evidence appears somewhat conflicting e.g. -

Silvers et al 2005; 72:211-8 - Prostaglandins, leukotrienes

& EFA.

Converging evidence suggests that omega-3 polyunsaturated

fatty acids have aetiological importance in depression. To

determine the effect of adding fish oil to existing therapy

in participants who were being treated for depression in a

community setting, 77 participants were randomly assigned to

receive 8 g of either fish or olive oil per day in addition

to their existing therapy. Fifty-nine (77%) participants

completed 12 weeks of treatment. Dietary, biochemical and

lifestyle factors were measured throughout the study. Mood

was assessed using the Short Form Hamilton Depression Rating

Scale (HDRS-SF) and the Beck Depression Inventory II. Sample

size calculations were based on the HDRS-SF. Intention-to-

treat and per protocol analyses were carried out using

residual maximum likelihood. There was no evidence that fish

oil improved mood when compared to the placebo oil, despite

an increase in circulating omega-3 polyunsaturated fatty

acids. However, mood improved significantly in both groups

within the first 2 weeks of the study (P<0.001) and this

improvement was sustained throughout. In conclusion, fish

oil was no more effective than the control as an add-on

therapy for depression in this setting.

There a Cochrane review in development (since 2003).

There are plenty of reviews already. For example, CNS Drugs 2003, 17,

1081-109. Ian Maidment's review is good too - Acta Psych Scand 2000, 102,


It will be interesting to see if the fish oils theory fades away now that

david Horrobin has died.

One of the consultants I work with is keen on trying fatty acids on inpatients

with treatment resistant depression/schizophrenia/bipolar disorder. We are

using Flaxseed Oil as she is not keen on fish oils because of the risk of

mercury poisoning.

The 3 patients who have been prescribed Flaxseed Oil have all slowly improved

but of course this was not a controlled trial and they were also being treated

with medication.

Ethyl EPA is a specific product produced by Laxdale, a Stirling based

company, which has been the basis of several trials in schizophrenia (just

put a certain Dr Horrobin into your search engines!).

There is also work on salmon oils in ADHD.

Laxdale have kindly supplied us with some ethyl EPA under an unlicensed

named patient arrangement for use in treatment refractory schizophrenia.

Some of the published work suggests that the DHA component of fish oils is

inactive or possibly anti-therapeutic and that the EPA component is the

therapeutic moiety in products such as MaxEPA etc.

Regarding 'fish oils' for schizophrenic patients:

This is a very hot are of research. Fish oils may reduce the symptoms of

bipolar disorder as well as other conditions. Omega-3 fatty acids are

believed to be one the active componets. A recent study at Harvard Medical

School followed 30 bipolars - some receiving omega-3 - the others olive oil

as the control. Patients taking the 'fish oil' were symptom free longer.

Even tough these studies are preliminary, they do suggest that low levels of

essential fatty acids in brain cell membranes ma underlie major psychiatric

illness. Doses

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The best advive is TO EAT MORE FISH. Patients (and non-patients) can benefit

from the mix of essential fatty acids in fish - especially cold, northern

water fish - sardines, herring, mackerel,wild salmon (better than farmed

salmon). Vegetarians can try flaxseed (highin omega-3). There are also

omega-3 enriched eggs available in parts of Europe and the U.S

Nothing on Superego-café.com regarding fishoils so far !

From the Evidence so far Important points to remember :-

1)Omega 3 is the active ingredient in Fish Oils, which is available in both plant and fish materials.

2) Eicosa Pentanoic Acid (EPA) & Docosa Pentanoic Acid(DPA) are the Active compounds in fish oils.There is some evidence that DPA is harmful & EPA is the beneficial compound(particularly its ethyl compound)

3) Some Evidence that it is better to get them through natural sources than Tablet form(due to concerns of mercury poisoning)

4) It is useful in Treatment Resistant Schizophrenia & Depression,ADHA & Alzheimer’s disease, apart from cardiovascular diseases.

5)Its side effects include mild gastric irritation, Halitosis, Bleeding causing Haemorrhagic strokes & heart attacks(although a rare event), should consult experts before giving in Diabetes, has drug interactions for example in with Digoxin.

6)it is relatively cheap.

7)DOH,RCPsych ,NICE,SIGN websites don’t have much info on fish oils.

8) UKPPG message boards were a better source of information about fish oil use in mental health patients.

9) Most work in this issue has come from limited group of researchers like David Horrobin & Prof.Malcolm Peet etc…

10)there are patient information leaflets available on the internet which are a source of information, but not specifically tailored to our patient population.

11)form 38 or 39 is an issue !(consent to treatment)

12)There is a Cochrane review in development since 2003.

13)Wikipedia is good place for some info on fish oils.

14)its use guided by current evidence is limited to treatment resistant Schizophrenia and Depression,ADHD &Alzheimers , that too as adjunctive to other standard treatment. Its efficacy is to be assessed after 3 months

15)Current recommended dosage is Omacor(414mg EPA) 5 capsules daily (or)

Maxepa(170mgs EPA) 10 capsules daily

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I don't know if this stuff is useful. I have tried to ensure the references are accurate. Moderators, please delete this thread if it is deemed as not so important.

If anyone out there has already done an audit on Fish Oil, can they message me in private, so that I could Plagiarise a few ideas from them !

Eagerly awaiting your responses.........

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There is a theory fully discussed in the book 'the madness of Adam and Eve; how schizophrenia shaped humanity' by David Horrobin. In this book there are quite a number of references to the psychiatrist Malcolm Peet based in Sheffield. The discussion goes as follows using the aquatic ape hypothesis that when hominids were evolving in the african plains they at one stage had to take to living in riverine areas, swamps and possibly slow moving rivers. It is proposed this helped with our bipedality as they would have been forced to use two legs. It would have been impractical to be on all fours in such circumstances. More importantly hominids switched to a predominantly fish diet which contained loads of unsaturated fats and oils. Our brains ballooned out as these unsaturated substances are necessary for neuronal connectivity and fast transmission.

   This continued in some form or the other until the advent of a settled culture and the invention of agriculture. Man now lived on saturated fat from domesticated animals. It is claimed that the first recounts and documentation about serious mental ilnness that resembled schizophrenia were noted from agarian cultures.

There is a bunch of other stuff but the take home message was that fish oils are good for cerebral development.

N.B. I rather like the aquatic ape hypothesis. Sort of tries to explain why homosapiens has significant less hair than other primate cousins, why we like to swim and other primates dislike water. Also our babies can be born under water and can be observed to swim shortly after birth.  

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so what are your standards? and what is the reason for doing the audit?

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I quite liked the 'madness of Adam and Eve' ideas, and the idea of attenuated mental illnesses being a useful survival tool in early hominid tribes. E.g. mild schizophrenia equating to being a shaman or preist, hypomania driving exploration, etc. It would be an hypothesis to explain the persistance of these illnesses through to modern times, if they had initially conferred some sort of survival advantage...

As for fish oils, I think its a reasonable idea. I wouldn't prescribe them as yet but if a patient wanted to take them I don't think I would try to put them off in any way.

Would make for an interesting essay question.........?

Good luck with the audit.

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Interesting hypothesis, will try to get my hands on a copy of the book.


The standards are mentioned in the 15 point summary in one of the posts above. in short Fish oils can only be used as an adjunct to psychotropic medication.Althought Alzheimer's,ADHD and Treatment resistant depression also have some evidence for omega 3, it best evidence is as an adjunct to clozapine in treatment resistant schizophrenia.

there are common side effects like halitosis etc. but bleeding & haemorrhagic strokes have hapened. so there should be 3 month evaluation of its efficacy & regular review for side effects.

My audit is 2 see if we are confirming to those standards or not & also to try & find out who initiated the idea of fish oils.My guess is its mainly come from patients.

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If you like these ideas Marman, try reading the naked ape by Desmond Morris also along with the human zoo, assuming you havent allready.

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to try & find out who initiated the idea of fish oils.My guess is its mainly come from patients.

really? i would doubt that. i've never had a patient ask if they can try fish oils. i did have a social worker last week ask if we should start someone on them for his treatment resistant aud hallucinations.

last year i did a rehab job at a slowstream rehab unit at which malcolm peat had been the previous consultant. there were several patients on fish oils. i've no idea if they had helped or not.

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Its Maram, not Marman :lol: sorry for nitpicking.......LOL!

Desmond Morris is an old favourite of mine. Yes, I have read it a while back, will refresh my memory today.


I work in a forensic unit, so there is a lot of user/carer empowerment within this group, so Yes, a lot of times, carers of patients in our hospital have asked for fish oils.

some consultants have also used it as adjunctive for clozapine & some patients are on it for cardiac/physical health causes.


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Some have , but the trouble is they are not compliant for long..... !LOL!

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Patients are not likely to ask for fish oils are they?  How many would know about it, and how many GPs or psychiatrists discuss the benefits of  Omega 3  to the patients when that short period of time is taken up discussing the efficacy of psychotropic medication?  How many psychiatrists actually take the time to look outside of pharmaceutically funded reasearch and literature in the first place to even realise that Omega 3 is very worthy of attention?  I wouldn't think there are many or there would be more widespread interest - which won't be encouraged by the pharmaceutical industry for obvious reasons.

Here are 7 videos presentations re NIH Workshop on Omega-3 Essential Fatty Acids and Psychiatric Disorders.  Although I believe these are 3 to 4 years old, maybe slightly more, they still an excellent source of information.

Re copyright:

'Richard Nakamura, Ph.D., Acting Deputy Director NIMH, Director, Office of Science Policy and Program Planning, NIMH.  

Copyright   This is a work of the United States Government. No copyright exists on this material. It may be disseminated freely. '  (The introduction)

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I'm sure that omega 3 fish oils are beneficial for general health and our patients tend to be an unhealthy bunch. If it helps with schizophrenia/cognitive deficits...great. Does it need to go on a form 38/39?

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It certainly sounds more promising than...lets take Strattera as an example.

Its taken a Swedish Court and the Freedom of Information Act to very recently release documentation about the thousands of adverse reaction reports received in the last 3 years that neither the MHRA, Eli Lilly, or the Swedish regulatory body would release.

As Strattera is being promoted as a 'new' drug for children with ADHD (rather than the failed antidepressant it actually is/was) its good to see that some psychiatrists here are taking their 'duty of care' and the welfare of patients seriously enough to be researching independently and making comparisons between efficacy/risks of drugs and other options such as Omega 3.

Nice to meet you all and, I expect, bye :-/

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LOL, I hope you're not asking me, Maverick - being 'not medically qualified' I wouldn't have a clue as to what form 38/39 is ::)

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In keeping with the previous post on hiding information, a recent cochrane review on Abilify published in the yellow journal this month highlighted 8 deaths in a trial that have not been reported. It was only found by the cochrane researchers after exhaustively searching the FDA website. Serious stuff and a pretty cutting article!

Thanks Gloriosa for your info on high-dose antipsychotics.

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You're welcome Maverick.  

Slow response huh?  It took me 5 mins to realise there was a Page 3 LOL.

While I'm still here  :-[ did you know that Pfizer, Eli Lilly and GSK miscoded clinical trial data of ADRs such as homicidality and suicidality under 'nausea' and various other little tricks?  For Lustral, Prozac and Seroxat respectively?

In case you didn't, here's the extracts:

'...Reports on these trials list patients who have committed suicide, and list those patients as being of a certain age and as having committed suicide at a certain point during the trial, when the patient in question has a very different age and the event in question happened at a completely different point during the trial...'.

'...Miscoding of suicidal act as emotional lability...'

' ...Lilly have resorted to treatment non-response and a range of other headings to code what happened...' [re coding/mislabelling suicidal acts happening on clinical trials]

'...records on Prozac, Seroxat/Paxil and Lustral/Zoloft, you will find cases of homicidality coded as nausea for instance...'

'...Discontinuation of patients from studies for primary adverse effects such as nausea when in fact there has been a suicidal act;...'

'...But it is also worth adding specifically that this has been a feature of all trials of Zoloft/Lustral, Seroxat/Paxil and Prozac throughout, as far as I can make out... '

I'm editing because this file shows some examples of what happens when they miscode serious life threatening adverse effects in that way:

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Interesting about strokes and Omega 3 - I've never found articles that have said that, do you know of any Marman?

SSRIs have induced strokes, there are 3 mentioned here:

Neurology 2002;58:130-133

© 2002 American Academy of Neurology

Brief Communications

Cerebral vasoconstriction and stroke after use of serotonergic drugs...'

Antipsychotics can cause pulmonary embolism so presumably stroke also?  Not being medically trained I have to guess on that.

'...Clozapine, an atypical antipsychotic used against positive and negative symptoms of schizophrenia has been associated with pulmonary embolism (PE), having the second most common cause of death among current clozapine users...'

Ritalin risks:

'case series. Findling RL, J Child Adolesc Psychopharmacol 1996 Fall;6(3):165-75

' ... This case series describes 7 pediatric patients ... and 4 adults ... whose ADHD and comorbid major depression were treated in a naturalistic open clinical fashion. . . . With the exception of one adult who had a 20 mm Hg increase in diastolic pressure on methylphenidate monotherapy at 22.5 mg daily, the administration and coadministration of these agents were not associated with significant changes in blood pressure or heart rate. . . . These cases support previous suggestions that adjunctive treatment with psychostimulants might be a safe and effective intervention . . .'

NOTE:   A 20 mm Hg increase in diastolic (the lower number) blood pressure can be very significant. Depending on the starting point, it can bring the blood pressure into the 'stroke range.' And 22.5 mg Ritalin is not a high dose for an adult - or even a child. 'Monotherapy' means he was on Ritalin alone, not the combination. Although it was one man, it is almost 10% of this sample. If 10% of a sample risks heart attack or stroke in a short trial, how can this be considered safe?...'

Risk with all psychotropic drugs:

'...Weight gain is associated with the use of many psychotropic medications, including antidepressants, mood stabilizers, antipsychotic drugs, and may have serious long term consequences: it can increase health risks, specifically from overweight (BMI = 25-29.9 kg/m2) to obesity (BMI > or =30 kg/m2), according to Body Mass Index (BMI), and the morbidity associated therewith in a substantial part of patients (hypertension, coronary heart desease, ischemic stroke, impaired glucose tolerance, diabetes mellitus, dyslipidemia, respiratory problems, osteoarthritis, cancer)...'

And of course coronary disorders, often listed in side effects on 'rxlist drugname side effects' and evidence such as in the recent case of Strattera:

'...The document told about 130 reports of suicidality in one month from treatment with Strattera. It told about 766 spontaneous reports of cardiac disorders and 172 of liver injury, and about 20 completed suicides. The 130 cases of suicidal and self-injurious behaviour were reported September 23 - October 25, 2005...'

Psychiatrists desperately need to start using evidence-based science, rather than relying on a £/$ billions profitmaking industry for information - too much damage is being done globally because the majority do not.

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I appreciate all the information you are posting here.please treat it as a response from a person who appreciates this.

Every medication has side effects.there is no medication without side effects. Its a question of balancing the risks and the benefits.if the benefits outweigh risks then that particular medication is given.Every doctor is trained to do that.simple as that.

Regarding side effects, if 1 patient has a serious side effect in the thousands & millions of patients who take it, then we don't consider banning the drug or not using the drug, we fill a yellow form available in the BNF and report to the appropriate authorities(apart from the local pharmacy & RMO etc.)

Drug trials have Phase -1 trials, which are tried on animals in labs.Phase-2 trials are on healthy volunteers & phase-3 trials are on the patient group. then side effects are evaluated & only then any particular medication is licensed.(thats my understanding)

this process costs hundreds and millions of pounds.Money no government(anywhere in the world) is prepared to spend on an experimental drug or intervention & no taxpayer is prepared to pay certainly.

After this there is post marketing surveillance(phase-4) where side effects of drugs are further found.some side effects are not seen in trials & only when given in a large sample, they are expressed & when they do, these medication are restricted or banned etc....... prolonged QT interval leading to sertindole being taken off the shelf by the company itself voluntarily, thalidomide causing phocomelia etc.. the examples are numerous.

Its easy slagging off major pharmaceutical companies. but they are doing a difficult job commendably. Yes the interaction between the medical profession & the industry needs to be more transperent & monitored , but any draconian measures will harm the public.

For every bad example, there are good examples too.

Finally this thread was started by myself as a discussion of fish oils being added to clozapine & if any other doctors out there had any audits on it. Yes, some deviation are understandable & are ok, but to turn it into anti pharmaceutical industry is not healthy.

Any discussion on fish oils as an adjunct to psychotropic medication is appreciated.

Anti this anti that....... this is not the thread for it, may be not even the appropriate forum.

Medicine as a profession has always been evidence based & infact the psychiatric exam for membership has critical appraisal as a part of it, to make sure doctors are aware of appraising evidence.

Hope you take this as a honest appraisal & constructive criticism without any malaciousness.

Thank You.

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Maram, thank you for taking the time to reply.

While I don't hold the same views on a number of issues, I take it as your view and how you see it, without any malice intended in the reply :)

Actually I was reading your Omega 3 earlier posts which is why I asked with regard to strokes.

I simply haven't come across any article where a stroke has been mentioned as a result of taking Omega 3 - and wondered, as you said there were some cases. whether you had any publications in mind where cases of stroke are recorded as having occured as a result of taking it?


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