It’s not easy to talk about the condition we call Schizophrenia these days. Much of the controversy is about long the term management, giving antipsychotic medication not to treat an existing problem, but rather to prevent relapses – the chronic treatment of the chronic patient. Our existing antipsychotic medications aren’t much fun to take – having side effects, and in some cases, irreversible and debilitating side effects. On the other hand, maintenance antipsychotics do significantly decrease the incidence of relapse. And the tendency of patients with Schizophrenic illness to spontaneously stop taking medications is legendary. Anyone reading this likely has an opinion about how to deal with maintenance antipsychotics, and mercifully, that’s not what this post is about so we can table that particular rhetoric and its usual discord for the moment.
One solution is to use depot antipsychotics meaning the patient gets a shot monthly rather than pill[s] daily. And in some instances, these depot injections have been court ordered – known as a form of the "forced drugging" bitterly opposed by many activists. Again, not exactly the topic here, but it’s getting closer. I think almost all of us agree that the first episode of Schizophrenia is a special case. While the course up ahead is unknown, most feel that our best chance of preventing a downhill course of illness is in how we handle that initial episode [we’d like to keep a psychotic break from ever happening at all, but efforts in that sphere have yet to bear fruit]. And that brings us to a case most of us know pretty well by now – Dan Markingson [his story is here].
Putting aside all the tragedy of that story for the moment, Dan was in a study for patients having their first episode of psychosis [CAFE]. It was a fairly straight-forward trial. The patients were blindly assigned to one of three Atypical Antipsychotics and followed for a year. You left the study one of three ways: Completion; Voluntary Withdrawal; Removed by a clinician [non-response]. This study was a clone of an earlier NIMH study, CATIE, except CAFE was acute rather than chronic cases. But that’s a big difference. The chronic patients in CATIE were known antipsychotic responders put on medication to see how long they would take it – a tolerability study. I can’t imagine treating a person with a first break with an unknown medication and dose. Treating an acute episode means adjusting the dose or changing drugs based on the response. I wouldn’t mind the patient or rater being blinded, but not the clinician. Had I been on the IRB, I’m sure I would’ve voted "no."
Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics
[PRELAPSE]
NCT02360319
The goal of this project is to show that the best possible option for preventing relapses in patients suffering from first episode [<1 year of anti-psychotic medication] or early phase [<5 years of lifetime exposure to anti-psychotic medication] schizophrenia is by enhancing medication adherence. The study is designed to answer the question of whether the use of long-acting injectable [LAI] antipsychotics early in the course of treatment can break the cycle of frequent relapse that affects so many patients with early phase schizophrenia. The participating research sites [not individual patients] will be randomly assigned to either medication prescribed by their treating physician [with no restrictions] or to a regimen that involves a monthly long acting injectable antipsychotic. The sites will be assigned on a one to one basis to either of the arms taking into account types of patient population and geographical area. Patients enrolled in the study will participate in regular assessments either over the phone or in person and be followed for a period of 2 years. The primary outcome measure is time to first hospitalization.
The drug here is Abilify Maintena®, the depot form of Abilify® [Aripiprazole]. So the study brings up two semi-separate issues: the use of depot medications to deal with medication compliance and the treatment of a first episode of Schizophrenia with a fixed dose of depot medication. This is a stopping place, but there’s more to come…
You write
‘On the other hand, maintenance antipsychotics do significantly decrease the incidence of relapse’
?????? I do not want to side track this discussion but I thought this point was not established due to the fact that Harrow’s studies and Wunderink” studies found the opposite and that there are very few other long term studies over 3 years??? If I missed the point do you mind clarifying for me?
Yes, I do mind. I’m aware of the much quoted Wunderlink and Harrow studies, but I’ve never seen them myself. This series of mine is clearly headed in a direction against the flow of antipsychotics for maintenance. I’ll get to Wunderlink and Harrow in due time, so insert “as 1boringoldman has been told for decades and seen to be true in his limited practice experience with psychotic patients.”
I really am sorry, and thank you for answering. I am new to your blog and my questions are really questions, because I am trying so hard to do the right thing.. For obvious reasons, it is so difficult for families to try and figure this out and it is not in any way ‘academic’ for us. Please feel free to ‘moderate’ this comment out as I just really wanted you to know I wasn’t trying to be argumentative.
Sally,
No need to moderate it out. I tried to respond honestly, but I have a bit of PTSD of my own from former commenters who have been relentless. As you will know, this is an area of great controversy and I come by my ‘guard up’ stance quite honestly. I was serious about getting around to Wunderlink and Harrow, but for the moment, I have other fish to fry. I apologize if my tone was too harsh. I promise that I come by my reaction honestly. After training, as a long term therapist I only saw a small number of patients with psychotic illness. I aimed for “medication free” with all of them, but because of relapses, I couldn’t bring it off until way down the road. I only have permission to discuss one of those cases [see 1. from n equals one… and the posts that follow]…
Mickey
Thank you for explaining this to me and for the reference to pertinent posts. ,I will certainly read those – I have found case studies and personal stories very useful for gleaning bits of information which sometimes resonate with our situation. I am sorry you were so attacked while writing truthfully. That is another thing about our world which I find hard to understand. I believe your blog is doing an enormous public service and I have heard that sentiment echoed often in the ‘reformer’ movement from psychiatrists but also from many people outside of psychiatry.