The Once and Future Abilify: Depot Injections for Everyone?


This column is partly a report on the marketing of Abilify, the atypical antipsychotic that has become America’s best-selling drug.   It’s also an appeal for advice and feedback from the RxISK and Mad in America communities, and a call for some brainstorming about strategy.  The plans laid out by drugmakers Otsuka and Lundbeck for Abilify’s future, and the cooperation they’re getting from leading universities, are alarming enough to me that reporting on them seems inadequate.  We need action, although I’m not sure exactly what kind.

Over the past month, has featured a series of articles on Abilify.  I kicked it off with “Dodging Abilify,” a look at the drug’s huge popularity with U.S. doctors and my own efforts to avoid taking it for depression.  “Abilify from the Inside Out” shared what RxISK had learned from the first 34 reports we received  from people on Abilify.  The third, “Abilify, Tourette’s and Me” was written by “DG,” a young man who described his own disastrous Abilify experience.  In the fourth, “Abilify, Tourette’s and You” DG described attempts to reach out to the FDA as it considered approving Abilify for Tourette’s syndrome.  I added a note about the legal shenanigans behind Otsuka’s effort to get Abilify approved for Tourette’s, just as the patent on the drug was about to expire.

I began the project as an Abilify skeptic.  The huge profits from the drug, which costs from $800 to $1,000 per month in the U.S., seemed to be driving its expanding use.  Its alleged advantages were being hyped, while its problems weren’t being talked about.  Abilify was costing states a fortune – $57 million in one year for the Medicaid program in Illinois – even as they cut vitally needed services.  By April, I had decided I’d be cheering when Abilify’s patent expired at the end of the month and cheaper generics hit the market.  Maybe the marketing machine would stop just long enough for people to figure out who, if anyone, actually needed this drug.

Otsuka has one plan up its sleeve that’s already much-discussed in the business and financial press: Brexpiprazole, a new drug that’s only slightly different from Abilify (aripiprazole).  This is a time-worn tactic for Pharma; for instance, Janssen’s new antipsychotic Invega (paliperidone) is actually just the main metabolite of its old drug Risperdal (risperidone).  Otsuka already has researchers running trials on brexpiprazole and praising it in the pages of medical journals – but the financial press notes they’re still having trouble “differentiating” it from Abilify.  Nothing new there.

Vanguard Research

Then I stumbled across an article in New York Newsday that stopped me in my tracks.  A new for-profit clinical trial group called Vanguard Research had just signed a $28 million contract with Otsuka to test Abilify Maintena, the depot injection form of Abilify, in “early-stage schizophrenia.”  People aged 18 to 35 who were suffering their first psychotic episode would be randomly placed on monthly long-acting injections of Maintena, and kept on them for two full years.  (A control group would get “usual care,” meaning they’d get whatever daily antipsychotic pill their doctor felt was best for them.)

This is a big departure from the conventional wisdom, in which doctors reserve depot injections for chronically psychotic patients who have repeatedly “failed” to take their pills as prescribed.  The justification given was that “medication adherence” was the key to maximizing recovery.  Maybe monthly injections could get new patients on the path to success right away, protecting them from relapse.  To emphasize this, Vanguard’s trial has been christened the PRELAPSE Study.

The real reason for the study, however, was spelled out with brutal clarity in the Newsday article.  Losing the patent on Abilify would cost billions – but Otsuka “could help offset revenue lost from the oral version if they can shift patients to Abilify Maintena … Vanguard’s clinical trial seeks to show that Abilify Maintena’s monthly injection reduces chances of a relapse in the early stages of schizophrenia compared with oral versions.”  The study hadn’t started, but the “right result” was predetermined.  That’s the polar opposite of real science – not to mention a doctor’s sacred oath to put the patient’s welfare first.  Yet the article had been proudly posted on the website of Long Island Jewish Medical Center.  Not only was this “nonprofit” hospital the majority owner of for-profit Vanguard Research.  Its chief of psychiatry, John M. Kane, owned the minority stake – and would also be the Principal Investigator on the PRELAPSE Study!


There are good reasons why even hard-core biological psychiatrists don’t use these injections for everyone.  They lock you in to a specific drug and dose (usually a high one) for a month at a time.  If you need a change of meds or a dose reduction, too bad.  Often they pack a particularly unpleasant wallop on the day of the shot.  They’re coercive; the main point is to defeat patients’ efforts to reduce or stop their meds, and patients know it.  They’re the method of choice when patients are court-ordered to either take their meds or be committed to a hospital.  Even when there is no court order, it’s hard for doctors to say they have a “therapeutic relationship” with someone they’re basically forcing to accept treatment.

For young people having their first psychotic episode, I knew, this could be disastrous.  For many, there’s no reason to assume they are in the first stages of a lifelong illness – especially if their voices, delusions or other extreme states come in response to a traumatic experience, drug use or a sudden big life change.  Doctors used to recognize a problem called “brief reactive psychosis” that might strike a person only once or twice in a lifetime, under unusual stress.  It wasn’t that uncommon, and often it would lift without any medication at all. In other cases medications could be used for a short time, and discontinued as soon as the crisis was over.

Forcing these young people to take a high-dose antipsychotic for two whole years would subject them to all the damaging effects for no good reason, while misleading them and their families as to the nature of their problem.  It might well condemn some to a long-term disability they would never have had otherwise.  Even for those who did appear to have a long-term problem that might be at least partly biological, long-term meds were a flawed answer at best.  The PRELAPSE Study would not just “risk” doing grave, possibly irreversible harm to some of its subjects.  It would be practically guaranteed.

Universities on the Take

In recent years people with psychotic experiences themselves, in alliance with open-minded professionals, are developing alternative ways to help people recover either with no meds at all or using  the least amount practicable.  These initiatives are now recognized and even encouraged in academic medical centers across the country, where “recovery” is declared to be psychiatry’s goal, and patient-centered care is everyone’s watchword.  Why, then, are so many respected academic medical centers signed up to participate in the PRELAPSE Study?  According to, they include Stanford University; Georgia Regents University; Emory University (in collaboration with Atlanta’s Grady Hospital); the University of Iowa; St. Louis University; the University of Florida; Creighton University in Omaha; and the University of Minnesota.  There are others, possibly including Dartmouth, Michigan State and the University of Cincinnati, which may be supervising PRELAPSE Study sites located at community mental health centers.

The University of Minnesota ought to be especially ashamed.  The decade-long coverup of the death of Dan Markingson in the CAFE Trial of atypical antipsychotics has finally led to a suspension of all psychiatric research, pending an investigation of the department’s treatment of human subjects.  None of the universities, however, seem to share Dr. Kane’s taste for publicity around PRELAPSE.  While the seven community research sites have all begun recruiting, not one of the eight university sites has started yet, according to  A Minnesota activist told me PRELAPSE was not on the list of research studies put on pause by the investigation, because it was still awaiting ethical approval from the university’s Institutional Review Board (IRB).

What Can We Do?

Could we get some or all of these universities to withdraw from PRELAPSE by campaigning to have this study rejected on ethical grounds?  It would not be easy.  Public opinion in the U.S. has been carefully shaped for years to see mental illnesses as brain diseases that science is well on its way to curing, and “people going off their meds” as the root of much of the misery and homelessness they associate with mental illness. Even some people who question the overdiagnosis of depression or ADHD still assume that “schizophrenics” really do need their meds, period.

Yet many people with first-hand knowledge of the issues will be surprised and disgusted that their local medical school has partnered with Otsuka on this study.  A little education could bring others onto our side.  If we succeeded, even at a few schools, it could not only deal a modest blow to Big Pharma, but help change the public discussion as well.  (It’s worth noting that Lundbeck, Otsuka’s European partner, has not dared conduct a study like this in Europe.  Instead they’ve backed a modified study targeting patients of all ages who have been diagnosed with schizophrenia for at least one year but less than seven years.)

But I’ve never been diagnosed with psychosis, or spent much time at a top academic medical center.  That’s why I’m looking for input from those who have.  What do you think we should do?

I met some people who were taking Abilify and were doing all right; they felt it caused less sedation and weight gain than the other antipsychotic drugs they’d been on.  Yet all of them were glad someone was writing about the side effects, and were concerned about its long-term impact on their health.


  1. Psychiatry just gets more and more terrifying all the time. I think that we need to remind the public that the medical industry and the former family members of Mad people are the only winners in this inhumane plot to imprison unwanted people in the mental “health” system. Another thing we really should try to accomplish is creating a sort of Underground Railroad for fugitives of pro-force psychiatry. At the rate this country’s going, a growing number of Mad people may have to go off the grid, at least for brief periods of time, in order to retain the small amount of liberty they still have.

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  2. It brakes my heart to read this! What is happening in the name of psychiatry and in society? How come this is possible to take place in a civil coutry/ world and how to make a change?
    I have been working for many years, but I never get used to “insanity” in the name of science, and to hear about this big Project involving a lot of Young people who have no idea what it will cause in their lives make me feel furiouse and sad at the same time.
    Anyway, thank you Johanna for getting the word out and let´s hope we are many enough who realize it has to be a change re the way people are met in crisis and the way we define ourselves and each other.

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  3. It is horrifying, I agree. Especially since some people are actually allergic to the neuroleptics, and this drug class is known to cause both the negative and positive symptoms of schizophrenia in some patients:

    “Neuroleptic induced deficit syndrome is principally characterized by the same symptoms that constitute the negative symptoms of schizophrenia—emotional blunting, apathy, hypobulia, difficulty in thinking, difficulty or total inability in concentrating, attention deficits, and desocialization. This can easily lead to misdiagnosis and mistreatment. Instead of decreasing the antipsychotic, the doctor may increase their dose to try to ‘improve’ what he perceives to be negative symptoms of schizophrenia, rather than antipsychotic side effects.”

    And when people who suffer an adverse reaction to a neuroleptic are misdiagnosed and mistreated, most often as noted above, by increasing the dose of the antipsychotic or adding another antipsychotic. The negative symptoms of schizophrenia may disappear, but the positive symptoms of schizophrenia will likely materialize via the central symptoms of neuroleptic induced anticholinergic intoxication syndrome:

    “neuroleptics … may result in … the anticholinergic intoxication syndrome … Central symptoms may include memory loss, disorientation, incoherence, hallucinations, psychosis, delirium, hyperactivity, twitching or jerking movements, stereotypy, and seizures.”

    The neuroleptics are not “wonder drugs,” they are drugs known to actually cause the symptoms of schizophrenia in at least a percentage of people.

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  4. My problem with ‘add-on’ anti-depressant drugs like Abilify and SEROQUEL is that they put me in ‘zombie mode’. I just wanted to sleep and literally do nothing when I was on them. I couldn’t focus very well at work and I couldn’t even attempt to make progress on my research. Cognitive Therapy seemed to be a much better solution than adding more meds.

    This was one time where I agree that the “cure” was worse than the “disease”

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  5. This is very scary indeed. It is my guess that there is fight brewing to get prodromal or pre-psychosis listed any future DSM, or comparable manual. Although doctors make the prodromal diagnosis out to be preventative, there is little indication that it isn’t ACTUALLY causative. After all, nothing is more preventative, when it comes to diagnosis, than non-diagnosis. I imagine that what is being called “early scizophrenia” could and will easily be extended to include what is being called prodromal or pre-psychosis. This is all about profiteering, and drug marketeering, and has little or nothing to do with health. You are very right in saying that something needs to be done. I happen to reside in a town housing one of the universities you mention as being involved in these studies of Abilify. It is certainly something we need to look into doing something about.

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    • I’m afraid you’re right, Frank: The boys at North Shore Long Island Jewish Med Center are also working on drug therapies for “Attenuated Psychosis Syndrome.” They’re looking for youth ages 12-25 (!) who have never been diagnosed with any psychotic disorder, but who pull at least one high score on a checklist of “prodromal symptoms.” Subjects will get either Abilify, 5 to 30 mg., or Prozac, 10 to 60 mg. This sounds risky as hell – maybe that’s why they haven’t gotten any universities to join.

      However, UCLA is conducting its own study of depot injections for young people with a first psychotic episode. It’s extremely similar to the PRELAPSE Study, except that the cosponsor is Janssen and its new injectable product, Invega Sustenna. Another group of studies is looking at both injections and oral clozapine as a first treatment choice, using the excuse that these medications might prevent “cannabis abuse” and “alcohol abuse” in younger patients.

      What do you think would be the best way to create some pressure on your local medical school and get them to think about dropping out of this mess? (I don’t know which professors, etc. are running the studies in each school, but it should not be too hard to find out.)

      Any ideas?

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      • I referred to the page to which you linked at Clinical Trials dot Gov. I had thought that the study of depot injections was being conducted here in Gainesville. Not so. They have not yet started recruiting at UF Jacksonville Medical College. 3 Florida locations are mentioned, that one is the only one in the state that hasn’t actually begun recruiting study participants yet. I think we can apply pressure on the medical schools, it’s just with the study itself being conducted in Jacksonville, that complicates matters a little. First comes education locally, and then maybe I can see about finding some people in Jacksonville who can initiate some kind of political action there. I’m not sure how doable a matter this might be, nonetheless, the way to find out is by trying to tackle it. The person responsible for recruiting study participants in Jacksonville is also, conveniently enough, Program Administrator for their Psychiatry Residency program.

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      • OMG, every time I think I see psychiatry hitting rock bottom, I read something like this and realize there is no rock bottom. We need to keep spreading the word, not only that drugs are the problem, but that there are better solutions. I have seen nutrient (orthomolecular) therapy work very well, and I would encourage every one, especially the NAMI famillies, to give it a try before becoming ensnared in the drug trap. I am not claiming that nutrient therapy (vitamins, minerals, probiotics, amino acids) is the sole solution for everyone. For some people, it might be; for most, I suspect, it will not be enough and other therapies and support will be needed. But the idea that nutrients alleviate symptoms much more effectively than drugs, without toxic side effects, should give everyone a pause before taking the drug plunge.

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  6. I think this is one of the most terrifying things that I have read.

    Will you you try to post this on other sites as well – I wonder if ‘one boring old man’ would post your post – brief psychotic episodes are very well recognized at major hospitals – that alone should make psychiatrists who do care stop short in their tracks as well when they hear about this study.

    Thank you so much for your efforts.

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    • Great idea! I will leave a note at 1BoringOldMan — he has written some good stuff lately about Abilify and its new little brother Brexpiprazole. Feel free to post this on any website, Facebook page or whatever where people might be interested.

      Another idea:

      One mental-health worker I talked to in Chicago was very bummed out to hear of this, because she “thought Stanford was a progressive place.” It made me think: Lots of these universities cherish their liberal reputation. Some even have a few people working on good, constructive recovery projects in other departments, or even in the med school, while the major funding goes to crap like this that leads in precisely the opposite direction. They see the innovative, progressive stuff as cover I’m afraid.

      At every one of these schools I bet there are academics (and students!) who would be horrified at what the other academics are up to, just a quarter-mile away. Some of them may even be willing to raise a little hell, who knows?

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  7. This is truly frightening. I would not have been able to discontinue the Abilify I was taking without my shrinks knowledge or consent if it was in the injectable form. That was 9 years ago. There was obviously no justification or benefit to its use whatsoever from my health perspective.

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  8. Disaster. Forgetting all the other problems – I took Abilify only once and I was so nauseated I could not do anything the whole day save for vomiting. If I got an injection and had the same reaction for a month I could have died from dehydration or at the very least require intensive care. I feel so bad for all the people who may suffer this in future.

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  9. The question is: at what addresses should we start writing angry e-mails?
    At this point all the tactics are necessary – informing whatever press will be willing to take it up (linking it to Dan Markinson’s story could be a catch), writing to schools, protesting outside the said institutions…

    There’s not end to psychiatric insanity. Lunatics running the asylum as they say.

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  10. Lots of good ideas coming in! To Frank, I’d say go for it — any poking around you can do in the U. of Florida, either Jacksonville or Gainesville, would be great. Especially if you already know people there, which it sounds like you do.

    Dr. Mickey Nardo has posted a 3-part series on this at . Very good too! He’s more conservative on the issue of antipsychotic meds than many folks here — for people with longstanding psychotic symptoms, he’s skeptical about prospects for recovery with out them. Yet he manages to explain beautifully why “locking in” a particular drug treatment for someone in a first episode is 1) totally unethical in general and 2) exactly how Dan Markingson died in that 2004 drug study. (He also gave links to this Mad in America article.)

    On another discussion, Dawn suggested MIA activists take part in the World Social Forum conferences this summer (late June I think) in Philly and the Bay Area. This sounds like a great chance to share agendas and ideas with all sorts of people fighting for their own liberation. The Philly conference is anchored by a longtime “welfare rights” and economic justice group and a disability-rights coalition. This study is just one of a whole lot of issues we could bring up there, of course.

    Just a note on the “Foreign Correspondent”: I live in Chicago, Kingdom of Cook County, IL. lives on the Internet; its activists are in the UK, Canada, USA, Ireland and New Zealand so far. The key medical advisors are in Ontario, CA (Dee Mangin) and North Wales (David Healy). Not sure what that makes us … but glad to be on MiA anyway!

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  11. When Abilify first came out; it was touted as a wonder drug. I was on risperidal at the time and then got switched to Abilify. Abilify caused me to have trouble swallowing; which I guess would lead to having trouble breathing. So, I was transferred back to the risperidal. I am disheartened when I see the magazine ads to seduce people to add abilify as an adjunct to their anti-depressant that that “would help them”. I noticed that you wrote that Invega is basically just a reformulation of risperidal. I got prescribed Invega and for maybe even a month; everything seemed almost better; but, it caused me insomnia and heart palpitations. Then; one night, my throat started making these strange and scary noises. I become worried that my throat would close up and I would not be able to breathe. So, I stopped the Invega and the throat problems magically disappeared in about two nights of discontinuance. When, I went to the psychiatrist; I told her that I wanted no more meds; but, she was scared of a “relapse” and prescribed me risperidal. I think it was the risperidal and perhaps the lithium and ssris that precipated the psychotic thoughts in the first place. After what I read in your article; I think it was highly medically unethical of her and possibly borders on medical malpractice after the problems I had had with invega. I refuse to take any meds again and I refuse to see her again.
    I am seeing someone in another city who I think was referred by this website. Sometimes, I just rage and then I take a walk and then I remember the Bible; “Vengence is mine saith the Lord!” This may not work for everyone and I don’t think it should. Our paths in life are unique; but, it helps me.

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    • Abilify caused me to feel nauseated and vomit for over 8h. Understandably my adventure with it finished after one pill (and lucky me). I have not taken a single psych drug which has not had terrible side effects and I’ve tried quite a few. They are really poisonous and the side effect rates that are reported are not even close to the real ones.

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  12. I have experienced psychosis (only once in my life, in 2012) and one of the neuroleptics I had to take in the mental hospital and for more than a month after my release was Abilify (in the form of tablets). It caused many unpleasant and disturbing side effects, from akathisia to drooling during sleep and the numbing of several of my fingers every night (the drooling and the numbing of my fingers were quite surprising and worrying).

    I did not feel like myself, I was unable to read a long paragraph in a book or even to have a normal conversation (I constantly felt as if I had nothing to say). All these side effects and problems disappeared as soon as I started coming off Abilify.

    This study where people experiencing their first psychotic episode would be put on Abilify long-acting injections for 2 years makes me really sad. You are so right in pointing out that psychosis is not necessarily a sign of a lifelong illness and that the injections may lead to disability (e.g. tardive dyskinesia).

    Psychiatrists diagnosed me with paranoid schizophrenia during my psychotic episode and claimed that I should take Abilify for at least 2 years. Fortunately I strongly felt that I should not listen to them, that I did not need “maintenance treatment” and that neuroleptics had a devastating impact on my life quality.

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