Viibryd, New generation SSRI availability?

MrSzyslak

Anyone know if this Drug has been approved in Ireland?

It was approved in the USA in 2011 but couldnt find any information on availability in Europe, which is strange as it was developed in Germany..

Nikita999

I would be interested in this also

JuliusCaesar

As we are psychologists and counsellors here, and do not prescribe, you might be better off asking in the medical forum.

Valmont

Given that SSREs (selective serotonin reuptake enhancers; approved in France in 2008) work just as well as SSRIs, I think we can finally put to rest the theory that depression is caused by a lack of serotonin. It seems the most important component of any drug designed to treat depression is that it has side-effects strong enough to be perceived by the user. When Astra-Zeneca developed the first SSRI with no noticeable side-effects, their share price took a tumble after their clinical trials showed no benefit over placebo whatsoever. In the standard double-blind randomised controlled trial, the group given the active SSRI breaks blind quickly in that the side-effects tell them which group to which they were assigned. Can you guess what happened in studies when the placebo produced side-effects similar to the active drug? No difference in outcome whatsoever!

Labarbapostiza

Valmont wrote: »

In the standard double-blind randomised controlled trial, the group given the active SSRI breaks blind quickly in that the side-effects tell them which group to which they were assigned.

Can you guess what happened in studies when the placebo produced side-effects similar to the active drug? No difference in outcome whatsoever!

Pray tell, do you know what was used as the sides inducing placebo?

There may be no difference because the sides are the treatment.

Valmont

Labarbapostiza wrote: »

Pray tell, do you know what was used as the sides inducing placebo?

There may be no difference because the sides are the treatment.

I don't understand any of this; could you clarify what you mean, please?

Labarbapostiza

Valmont wrote: »

I don't understand any of this; could you clarify what you mean, please?

If they were using a placebo that induced similar side effects to that active substance under test, then I there was no difference, then it is possible that the side effects themselves are the therapeutic effects.

But I'd like to know what they used as a placebo?

Valmont

Labarbapostiza wrote: »

If they were using a placebo that induced similar side effects to that active substance under test, then I there was no difference, then it is possible that the side effects themselves are the therapeutic effects.

Yes that is the exact point I was making - it wasn't the active SSRI but instead the belief and hope that came with realising they were in the group being treated with the promising, new, and experimental anti-depressant. Although I think saying that the side-effects per se are therapeutic is missing the point and the power of meaning. I don't think we can legitimately claim we have any theoretical basis for your idea that headaches are powerful therapeutic agents for depressed people!

Labarbapostiza

Valmont wrote: »

Yes that is the exact point I was making - it wasn't the active SSRI but instead the belief and hope that came with realising they were in the group being treated with the promising, new, and experimental anti-depressant.

Well, there is a big problem with these tests. Unlike testing a blood pressure medication against a placebo, where you can measure blood pressure; an easy observable. The tests depend on subjective responses. Which gives metrics that can be very poor. A severely depressed person may say they feel quite good, someone with very mild, or really isn't depressed just generally unhappy, may say they're going through hell.

I don't know what they were using as a placebo. It could have been an antidepressant that failed in tests, but was just as effective as an antidepressant as the SSRI under test.

The clinical trials really only indicate the drug won't kill people. The pharmaceutical companies are not consciously putting complete duds on the market. It's very hard to pin point whether truly depressed people have benefitted from these drugs.

I believe why people are so keen on Viibryd, is the promise that is doesn't effect sexual function as much as other drugs. But I believe that sexual dysfunction from these drugs is an indication that they may be hitting their targets in the brain.

Although I think saying that the side-effects per se are therapeutic is missing the point and the power of meaning. I don't think we can legitimately claim we have any theoretical basis for your idea that headaches are powerful therapeutic agents for depressed people!

No, the drugs work in different ways. A drug that clouds thought might interrupt psychotic thinking, if that's the root of the depression.

Valmont

You seem to be disagreeing with me, Labarbapostiza, although you haven't clearly stated why, on what points, and on what grounds. Nevertheless, my original post in this thread was a critique of the chemical-imbalance theory of depression; specifically that depression is caused by a lack of serotonin in the brain. I have some more research to bolster my point, if the last few studies I mentioned didn't convince you (and which you haven't refuted):

• Over ninety studies have experimentally lowered the amount of serotonin, norepinephrine, and dopamine in healthy volunteers to levels that should -- in theory -- have produced depression. A meta-analyis of these studies in 2007 concluded that the intervention produced no depressive effects whatsoever.
  
• The oft-cited statistically significant difference between active anti-depressants and placebos is not actually clinically significant. Clinical significance is of more importance than statistical significance because it actually takes account of the effect of a drug on a person's quality of life. The average improvement experienced by somebody given an active SSRI over an inert placebo is a 1.8 point reduction in depressive symptoms, as measured by the Hamilton rating scale. A two point reduction can also be garnered by fidgeting less during the interview, or by eating better. Regular exercise will produce a benefit of up to six points!
  
• Regarding your claim that pharmaceutical companies wouldn't deliberately put a dud on the market, you may want to first explain why they withheld dozens of negative clinical trials from publication, published positive data sets multiple times in different papers, published data that was different to that which they submitted to regulatory agencies, and in various multi-site studies they selectively left out sites that did not find a positive result for the drug under consideration.

Taking half a century of research, the chemical-imbalance theory of depression has been almost entirely refuted (I have a large folder on the table in front of me and my posts in this thread barely scratch the surface!). Naturally, we have to ask why drugs that target this non-existent mechanism of action are still being peddled when they cause unpleasant side-effects and cost a lot of money, both to private patients and tax-payers. Considering psychologists should be concerned with evidence-based treatments, there is a large ethical question mark over the endorsement of such pseudo-medicines.

Labarbapostiza

Valmont wrote: »

Naturally, we have to ask why drugs that target this non-existent mechanism of action are still being peddled when they cause unpleasant side-effects and cost a lot of money, both to private patients and tax-payers.

Why?.....I will tell you why. My subjective experience is they work, because I have used them. And it's not my imagination, each one I have used has been distinctly different.

I think you're the one being irresponsible. Discouraging people from trying them amounts to medical advice. They can be a turning point in peoples' lives.

Considering psychologists should be concerned with evidence-based treatments, there is a large ethical question mark over the endorsement of such pseudo-medicines.

Well I'm sure there have psychologists who have had positive personal experiences with these drugs.

Valmont

Labarbapostiza wrote: »

Why?.....I will tell you why. My subjective experience is they work, because I have used them. And it's not my imagination, each one I have used has been distinctly different.

Anti-depressants do work, but not by righting any alleged chemical imbalance in the brain. There is an unassailable body of research pointing to the conclusion that the therapeutic benefit experienced by people on anti-depressants is a placebo effect, or as I prefer to call it, the meaning response. This doesn't mean that anyone is being tricked, or is foolish for 'falling for it', but simply points to the profound influence that expectations, beliefs, and attitudes have on recovering from personal problems of any severity. Personally, I am of the opinion that psychologists need to work towards promoting therapeutic means of harnessing the meaning response, and I don't think anything works as well as CBT in that respect.

Labarbapostiza wrote: »

I think you're the one being irresponsible. Discouraging people from trying them amounts to medical advice. They can be a turning point in peoples' lives.

This is completely irrelevant. As long as psychology wants to stay a science then people have to confront the research directly; even if that means arriving at conclusions which are difficult to accept.

Labarbapostiza

Valmont wrote: »

Anti-depressants do work, but not by righting any alleged chemical imbalance in the brain.

My believe is that many people do have a chemical imbalance, but many people prescribed with antidepressants do not.

There is an unassailable body of research pointing to the conclusion that the
therapeutic benefit experienced by people on anti-depressants is a placebo
effect, or as I prefer to call it, the meaning response.

No, I believe this unassailable body of research is based on false or inaccurate assumptions. If you take someone who has not had a traumatic life, and then they're exposed to a single traumatic event, like a death of a loved one, and they experience depression. The experience is due to the meaning of the death. They need to re-regularise their thinking, back to when it was not traumatic.

But if someone experienced prolonged repetitive trauma the functioning of the brain may have completely changed, and simply meaning will not re-regularise it. EEGs of the brains of people with complex PTSD and PTSD show different functioning - cognitive impairment when exposed to certain stimuli.

This doesn't mean that anyone is being tricked, or is foolish for 'falling
for it', but simply points to the profound influence that expectations, beliefs,
and attitudes have on recovering from personal problems of any severity.

Yes, if they have beliefs, then a magic ritual might work. An exorcism being an example. These still go on in the world. There is tension in a family = the family projects this onto one member, usually a child. The witchdoctor or Seer, or Catholic priest, is called. They perform an exorcism. If everyone in the family believes an evil spirit has been cast out, then the madness in the family might vanish. But it depends on belief. What's happened is a pathological delusion, has been replaced with a less harmful delusion.

In our society there are many pieces of "magic" used to make people by products and feel better about themselves. "Organic" food. "Diet" versions of foods.


But also If you were my client and you believed me to be an incredibly powerful psychoanalyst. If you attended a session with me, and all I did was read short extracts from Finnegan's Wake, in a stern voice, to make it sound more meaningful. And then dismissed you after five minutes. The process of you thinking about the session, might be therapeutic - but I also have a fear, it could make someone more psychotic.

Personally, I am of the opinion that psychologists need to work towards promoting therapeutic means of harnessing the meaning response, and I don't think anything works as well as CBT in that respect.

But CBT requires cognitive function to work. If someone has impaired cognitive function, it has no grounds to be effective.

This is completely irrelevant. As long as psychology wants to stay a science then people have to confront the research directly; even if that means arriving at conclusions which are difficult to accept.

Science is about measurement and not meaning.

There are practitioners nowadays taking things like "mindfulness" training seriously. What is it? It's Buddhism without the Buddha.

There's a little to what can be objectively analysed when it comes to the mind.

Valmont

Labarbapostiza wrote: »

My believe is that many people do have a chemical imbalance, but many people prescribed with antidepressants do not.
....
No, I believe this unassailable body of research is based on false or inaccurate assumptions.

I have presented summaries of numerous studies which completely contradict the chemical imbalance theory of depression. Do you have an argument to support your belief that these studies are flawed? Which studies? On what grounds? If depression is caused by a lack of serotonin then why do SSREs, which decrease serotonin levels, work just as well as SSRIs? Why do dozens of studies demonstrate that more important than the mechanism of action of the drug, is whether it produces noticeable side-effects? Can you explain why thyroid medication, barbiturates, benzodiazepines, and anti-psychotics all work just as well as SSRIs even though they don't address the alleged monoamine deficiency?

Edit: I will gladly provide any references on request.

Labarbapostiza

Valmont wrote: »

I have presented summaries of numerous studies which completely contradict the chemical imbalance theory of depression. Do you have an argument to support your belief that these studies are flawed? Which studies?

On what grounds?

Yes. On the grounds no one can make up their minds as to what depression is.

If depression is caused by a lack of serotonin then why do SSREs, which
decrease serotonin levels, work just as well as SSRIs? Why do dozens of studies demonstrate that more important than the mechanism of action of the drug, is whether it produces noticeable side-effects?

There was a time when you blamed the patient, then the parents, then the chemistry; because the parents became so annoyed.

Can you explain why thyroid medication, barbiturates, benzodiazepines, and
anti-psychotics all work just as well as SSRIs even though they don't address the alleged monoamine deficiency?

Maybe, all with the exception of thyroid medication, "work" by causing impairment. If anxiety is excessive it will not allow depression causing traumatic memories to be effectively processed - depression itself could be a natural impairment to assist in some kind of self repair but like anxiety; a little is essential, too much is crippling.

SSRIs are safer than barbiturates or benzodiazepines.

Valmont

Labarbapostiza wrote: »

Yes. On the grounds no one can make up their minds as to what depression is.

Which papers, exactly? Which of the studies I have referred to have conflicting definitions of 'clinical depression'? How would you define depression? And how does your definition lead you to be so certain that the monoamine hypothesis is correct?

Labarbapostiza

Valmont wrote: »

Which papers, exactly? Which of the studies I have referred to have conflicting definitions of 'clinical depression'? How would you define depression?

The DSM IV defines depression as a person having at least 5 of a list of 9 symptoms. A story I've heard; a researcher met with one of the compilers of the DSM, and was keen to know what statistical method had they used to arrive at 5 out of 9. And his answer was; oh no, we didn't use any method. 5 just about nailed it.

There's your "science".

And how does your definition lead you to be so certain that the monoamine hypothesis is correct?

I'm really not certain the hypothesis is correct, or incorrect either.

For a proper science you need measurement; the subject needs more measurement.

Valmont

Let me get this straight - you're defending the monoamine hypothesis against my specific criticisms on the grounds that you contend the DSM's definition of depression is arbitrary? That doesn't make a whole lot of sense, labarbapostiza. You seem to want to defend the idea of depression as a biological illness but simultaneously dismiss the idea that it is something we can treat scientifically; logic dictates you can't have it both ways, unfortunately. Perhaps if you could state clearly what your point is and why you disagreed with my original post?

Valmont

By saying that you are not certain whether the monoamine hypothesis is correct or incorrect because we have an inability to gain any objective measurement of depression, you are painting yourself into an epistemological corner. If we take your stance further, you could equally argue you are not certain whether the pull of the moon or a zodiac sign makes people depressed.

The research I have cited uses self-report measures to determine whether somebody is depressed or not, and then attempts to quantify improvements using the Hamilton rating scale. This is far from objective but it does allow for experimenters to determine if the subjective improvements associated with a particular drug are likely to be from the alleged chemical action of that drug, or something else entirely, such as the placebo effect. The research I have cited almost conclusively tells us that the subjective improvement experienced by depressed people is not due to the manipulation of their monoamine levels.

Labarbapostiza

Valmont wrote: »

If we take your stance further, you could equally argue you are not certain whether the pull of the moon or a zodiac sign makes people depressed.

There are just so many variables you cannot control in testing. Each person will be engaging with their environment differently. And they will engage with themselves differently.

One major problem of psychology as a science, is when variables are not easy to control, or measure, they're often disregarded. The other major problem, is people believing elements that are no better than the horoscope to be scientific theory.

The monoamine theory, has it's origins in Freud noticing how fantastic he felt on cocaine. Well, other doctors stole his thunder by publishing before him, but he did write Uber Coca.