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April 22, 2013 by Sandra Steingard, MD

All Sorts of Realities

In previous posts in this series, I noted that the standard treatment of conditions labeled as schizophrenia (and related disorders) is to start neuroleptics early and to continue them indefinitely. This is based on the belief that untreated psychosis is bad for the brain and that relapse is much higher when the drugs are stopped than when they are continued. The rationale for this approach, and my discussion of the limitations of these assertions, were the topics of previous blogs in this series.

In this final post I want to discuss how realistic this paradigm of care is. Many people just do not want to stay on these drugs. This has resulted in a system of care in which an incredible amount of resources are spent on insuring that people take them. In much of the discussion on this topic, we tend to focus on people who stop them completely. But there is another aspect to this story – the impact of missing a few doses. This happens with most people who are prescribed long term medications not just those who are prescribed medications for psychiatric problems. This happens even when a person’s intention is to take the drug as prescribed. What are the impacts of these “mild” periods of so-called “non-compliance”? (I have come to appreciate that this is a trigger word that offends some of my readers. Please understand that it is a failure of my writing skills that I have employed the term used most often in the psychiatric literature.)

A study by Subotnik and colleagues (Am J Psych 2011; 168:286-292) asked this question in a group of 49 individuals who were enrolled in an intensive outpatient program for early episode psychosis. They define non-compliance as follows in the following chart:

Category Definition Participants Meeting Criteria during Follow-Up Assessment (%)
Severe Compliance with <50% of the prescribed oral risperidone dose for ≥4 consecutive weeks or dropped out  19
Moderate Compliance with <50% of the prescribed oral risperidone dose for at least 2 but <4 consecutive weeks  16
Mild Compliance with 50%—75% of the prescribed oral risperidone dose for at least 2 consecutive weeks  33
Adherent Does not meet any of the above criteria  32






What they find is that there is a 5.8 times risk of relapse with even mild non-compliance and there is no statistical difference between mild, moderate, and severe non-compliance. In a study in which subjects were motivated to participate in an intensive treatment program, close to 70% of individuals had some periods of “non-compliance”.

I participate in a group with other psychiatrists and we sometimes read articles together. I had raised the question about how long someone should remain on neuroleptics that had been started after a first experience of psychosis. It was suggested that we recommend that they are never stopped because the rate of relapse is so high even with very minor breaks in treatment.

It is interesting how people can respond to the same information in different ways. The above interpretation, in my opinion, is justified only when “relapse” is viewed as a uniformly disastrous outcome that supersedes all other bad consequences of taking these drugs long term. I just do not see it that way. I have experience tapering these drugs and with some people a recurrence of say, hearing voices, may lead to only to a phone call in which we discuss various options including increasing the dose of a neuroleptic drug. There is no hospitalization, no disruption in work or social relations, no dangerous behavior. This is not how it goes with everyone but, thus far, reductions of dose can be handled in an outpatient setting with the majority of my patients.

This brings me to my conclusion.

In my opening post, I made the following assertions:

  • The impression of short term efficacy tends to be inflated.
  • The impression of long term risk tends to be minimized.
  • The impression about the risks of delaying treatment (Duration of Untreated Psychosis) with antipsychotics is inflated.
  • Although antipsychotics are sometimes remarkably effective in reducing psychotic symptoms, this does not mean that they are always required.
  • Compliance is low despite our recommendations so it is almost impossible to comply with recommended guidelines.
  • Relapse does not carry the same risk for all individuals.

In the subsequent posts, I presented data to support this:

In several recent large studies published in major journals, neuroleptics were found to be, at best, moderately effective in the short term.

I pointed out that it is now accepted that long term exposure to these drugs increase the risk of tardive dyskinesia, weight gain, and metabolic syndrome (diabetes, high blood pressure and elevated lipids). I reiterated the Whitaker argument that while there are not many studies that look at outcome beyond two years, those that have been done suggest long term outcome may be worse for those who remain on these drugs.

Although delay in initiating treatment may lead to worse outcome, treatment does not need to be synonymous with drug treatment. People who received early psychosocial treatments had better outcomes that was independent of when drugs were started.

Most people choose to not take medications as consistently as recommended and, once started, even short periods of time off the drugs increases the risk of relapse.

As I put this together, I come to the following conclusions:

  • Since many people choose to stop, since some may get better without medications, since some may be able discontinue with slow taper, and since relapse is not universally a disaster; we should revise practice standard to try to wait before starting drugs, and (having started them) consider discontinuation in a controlled manner.
  • Since these drugs are not as effective as most people think, we should approach failure to respond with more judicious use of drugs rather than by adding on more drugs.
  • The current practice of recommending that almost all individuals remain on these drugs indefinitely should be challenged.
  • We need to reconsider what we consider informed consent.

The point I am trying to make is that practice is currently guided only to a limited degree by the data. Yes, these drugs can be dramatically effective in the short term for some people and, yes, there is a higher rate of relapse when they are stopped; but it is also true that the benefits that some people derive from these drugs do not clearly outweigh the risks.

I mentioned Daniel Kahneman’s book, Thinking, Fast and Slow in my introductory post. He writes about the great power of intuition but he also discusses its limitations. He points out that intelligence does not protect one from the limitations of our cognitive systems and I suspect that those of us who have had years of education and training may be more prone to overvalue our intuitive capabilities than others.

If you graduate from medical school and complete 4 years of post graduate training and through that entire time you have been told how powerful the neuroleptic drugs are – they helped close down the state hospitals, after all – then you may be inclined to remember more vividly the patient who had a dramatic improvement after taking a drug and dismiss as an exception the one who showed no improvement. You might explain the poor outcome in a person who has been taking neuroleptics for years as a reflection of the progression of the underlying disorder and view the story of the person who stopped taking drugs and did well as a reflection of that small minority who we always knew could do well.

A disproportionate amount of psychiatric residency training is on inpatient units where people are not at their best. There is scant opportunity to work with individuals who are coming off drugs or doing well – why would they be in our offices or inpatient units, if they were doing so well? All of this lays down a framework for thinking about psychosis that influences people for many years into the future.

The whole issue of “relapse” is fraught with value judgments. If the goal is to minimize any and all psychotic symptoms no matter the extent to which they interfere with a person’s ability to live a full and satisfying life, then perhaps one could justify a practice standard that has everyone start these drugs early and remain on them for life. I talk frequently with individuals whose symptoms are serious and sometimes frightening. They get into legal trouble or they put themselves in harm’s way. Their families plead for help not out of a sense of control but a sense of desperation for their loved one. At the same time, I also talk to individuals who are miserable when taking these drugs. All of these people deserve an ongoing discussion of the risks and benefits of these drugs including what we know and do not know; not only about these drugs but also about the conditions we are trying to treat.

There are all sorts of realities here and it seems that the available data supports being flexible.

Thank you for reading and for sharing with me your stories, information, links, and insights.

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