Aripiprazole

[GasDoc]

ME/CFS is likely to represent a mixed group of conditions, with many different triggers that leads to a common group of symptoms. It has been shown that there is both central and peripheral nervous system involvement and there is emerging evidence that brain inflammation is central to its aetiology. The core symptoms of ME/CFS include debilitating fatigue, unrefreshing sleep, post-exertional malaise, and either cognitive dysfunction or orthostatic intolerance.

With respect to CNS involvement there is evidence from PET scanning that activated cells in the brain are present in patients with ME/CFS. Dopamine appears central to this and Dpoamine D2 receptor agonists can mediate this neuroinflammation. Dopamine modulating drugs could be of use in treating the central nervous system symptoms of ME/CFS.

So, what appears to have happened in this retrospective audit was a team from Stanford used aripiprazole, a pretty potent antipsychotic with an impressive range of potential side effects, in an "off-label" treatment of 101 patients.

This was not a study, no ethics, blinding, crossover, placebo, etc was involved, so it represents a low level of evidence for effect, but is an interesting and impressive set of results all the same.

The age range was from 18 to 84 years old (mean 50 years), with 67% female and 33% male, and the duration of illness was from 1 to 54 years (median 13 years). The duration of aripiprazole therapy ranged from less than one month to 17 months (mean 7.8 months).

For the responders the results were dramatic, of the 101 patients taking aripiprazole, 75/101 (74%) experienced an improvement in one or more categories: fatigue, brain fog, unrefreshing sleep, and frequency of post-exertional malaise (PEM) episodes, or “crashes.” Twelve individuals (12%) had no observable difference in symptoms at the maximum dose of 2 mg, and 14 individuals (14%) reported worsening of symptoms or onset of side effects that led to discontinuation of the drug. In the responders 6 were able to return to work and 4 reported improvement in their movement disorders.

The obvious weakness of this "study" is that it is a retrospective analysis of a group of patients treated with an off-label drug with all the biases that come with this. However, like a lot of studies of this type it gives a clue as to where research should be directed. I'll leave you with the summary from the paper.

"In summary, the number of positive responders in a group of 101 patients taking aripiprazole was significantly greater than the number of patients who did not respond or had negative experiences. Also, the magnitude of perceived improvement was significant. Some patients failed to observe any benefit, and a small subset of patients experienced side effects that required the medication to be discontinued. Overall, these results suggest that aripiprazole may effectively reduce symptoms of ME/CFS and warrants further investigation in a randomized clinical trial. Exploring the mechanism of action for aripiprazole in neuroinflammatory conditions may also provide new insight into the pathogenesis of ME/CFS."

I'll keep an eye on the clinical trials register https://clinicaltrials.gov to see whether a trial is registered this year following the publication of this paper. If so, I'll tag it into the most relevant forums.

For a link to all registered ME/CFS studies -

ClinicalTrials.gov

clinicaltrials.gov

 

[JameDiagonal]

This is an interesting link, thanks for sharing this.

 

[Morgoth03]

Good to know, thanks!

 

[konad2009]

I was one of the patients in this study.


I had been seeing Dr Bonilla since early 2020 and taking low dose abilify prescribed by him from February 2020 through February 2022. This was not a retrospective study. I started taking this medication under the impression it was an approved well studied treatment for ME/CFS. Immediately after the first month of taking it he started collecting scientific data / subjective patient reports from me on all of my symptoms. I know this because I recorded some of our appointment, including my 1 month follow up. The entire appointment was centered around the Abilify and data collection. Which I didn't understand at the time. I still have this recording.


These phone calls and data collection continued every two weeks to a month for the entire time I was on this medication. It was patient experimentation without informed consent. By the time this paper was published or maybe a month afterwards I was on roughly 2 mg a day and started having major cognitive decline, lapses and memory etc. he then continued the medication for another year getting me up to 4mg daily. Collecting data the whole time.

I got to the point where I was completely non-functional, bed bound with In-Home Care as a result of his experimentation. I did not know this was an experimental protocol. All of my memory and cognitive symptoms went away when I stopped it in 2022. It was horrific and cost me so much of my life. There were days that went by where I forgot half of what had happened. I got to the point where I would start to say something but couldn't remember what I said the previous sentence or where I was going with the conversation.

I thought that at least someone should know that nothing about this study was retrospective, at least in my case. It was labeled as retrospective to get through the red tape and consent requirements and protections that human research subjects would be afforded.

For me, it got so bad that his office staff labeled me as incapable of making medical decisions as a result of this experimental protocol. Had this an actual study in the traditional sense they obviously would have halted Aprilrizole treatment instead of escalating. However they continued to escalate for an additional year. Without me fully understanding what was going on.

Just wanted to let someone know. I don't know what the other patient's experience is were, but I know what mine was.

What he did and what Stanford did was highly unethical and illegal.

 

[Sarah R.]

Dreadful. I'm so sorry. Thanks for telling us.

 

[RenW]

I'm really sorry that some people react poorly to low dose Abilify (Aripiprazole). I'm taking it right now and it is helping me. I worked up to the 2mg dose which I've been at for over 3.5 years. It helps mostly to keep me from going into PEM and my severity and duration of PEM. I'm seeing an ME/CFS specialist and many of the treatments we discuss are experimental. That is a byproduct in the poor funding and quality of medical research for ME/CFS. I'm not saying that all ME/CFS research is poor but historically many of the studies were. This has improved more recently thankfully.

​

 

[AnniePipsqueak]

I was one of the patients in this study.


I had been seeing Dr Bonilla since early 2020 and taking low dose abilify prescribed by him from February 2020 through February 2022. This was not a retrospective study. I started taking this medication under the impression it was an approved well studied treatment for ME/CFS. Immediately after the first month of taking it he started collecting scientific data / subjective patient reports from me on all of my symptoms. I know this because I recorded some of our appointment, including my 1 month follow up. The entire appointment was centered around the Abilify and data collection. Which I didn't understand at the time. I still have this recording.


These phone calls and data collection continued every two weeks to a month for the entire time I was on this medication. It was patient experimentation without informed consent. By the time this paper was published or maybe a month afterwards I was on roughly 2 mg a day and started having major cognitive decline, lapses and memory etc. he then continued the medication for another year getting me up to 4mg daily. Collecting data the whole time.

I got to the point where I was completely non-functional, bed bound with In-Home Care as a result of his experimentation. I did not know this was an experimental protocol. All of my memory and cognitive symptoms went away when I stopped it in 2022. It was horrific and cost me so much of my life. There were days that went by where I forgot half of what had happened. I got to the point where I would start to say something but couldn't remember what I said the previous sentence or where I was going with the conversation.

I thought that at least someone should know that nothing about this study was retrospective, at least in my case. It was labeled as retrospective to get through the red tape and consent requirements and protections that human research subjects would be afforded.

For me, it got so bad that his office staff labeled me as incapable of making medical decisions as a result of this experimental protocol. Had this an actual study in the traditional sense they obviously would have halted Aprilrizole treatment instead of escalating. However they continued to escalate for an additional year. Without me fully understanding what was going on.

Just wanted to let someone know. I don't know what the other patient's experience is were, but I know what mine was.

What he did and what Stanford did was highly unethical and illegal.

I am so sorry you were put through this awful experience by what seems to be a dispicable medical professional. You sought help for an existing medical condition only to be experimented upon, ending up far worse than when you started. Highly unethical!! If you have the energy I would urge you to report this .... but it could result in a long term legal battle, and with a chronic fatigue condition this may seem insummountable and impossible.
Thank you for sharing your story, I hope you are in a better space now and recovered from this ordeal 🙏

 

[Aidan Walsh]

ME/CFS is likely to represent a mixed group of conditions, with many different triggers that leads to a common group of symptoms. It has been shown that there is both central and peripheral nervous system involvement and there is emerging evidence that brain inflammation is central to its aetiology. The core symptoms of ME/CFS include debilitating fatigue, unrefreshing sleep, post-exertional malaise, and either cognitive dysfunction or orthostatic intolerance.

With respect to CNS involvement there is evidence from PET scanning that activated cells in the brain are present in patients with ME/CFS. Dopamine appears central to this and Dpoamine D2 receptor agonists can mediate this neuroinflammation. Dopamine modulating drugs could be of use in treating the central nervous system symptoms of ME/CFS.

So, what appears to have happened in this retrospective audit was a team from Stanford used aripiprazole, a pretty potent antipsychotic with an impressive range of potential side effects, in an "off-label" treatment of 101 patients.

This was not a study, no ethics, blinding, crossover, placebo, etc was involved, so it represents a low level of evidence for effect, but is an interesting and impressive set of results all the same.

The age range was from 18 to 84 years old (mean 50 years), with 67% female and 33% male, and the duration of illness was from 1 to 54 years (median 13 years). The duration of aripiprazole therapy ranged from less than one month to 17 months (mean 7.8 months).

For the responders the results were dramatic, of the 101 patients taking aripiprazole, 75/101 (74%) experienced an improvement in one or more categories: fatigue, brain fog, unrefreshing sleep, and frequency of post-exertional malaise (PEM) episodes, or “crashes.” Twelve individuals (12%) had no observable difference in symptoms at the maximum dose of 2 mg, and 14 individuals (14%) reported worsening of symptoms or onset of side effects that led to discontinuation of the drug. In the responders 6 were able to return to work and 4 reported improvement in their movement disorders.

The obvious weakness of this "study" is that it is a retrospective analysis of a group of patients treated with an off-label drug with all the biases that come with this. However, like a lot of studies of this type it gives a clue as to where research should be directed. I'll leave you with the summary from the paper.

"In summary, the number of positive responders in a group of 101 patients taking aripiprazole was significantly greater than the number of patients who did not respond or had negative experiences. Also, the magnitude of perceived improvement was significant. Some patients failed to observe any benefit, and a small subset of patients experienced side effects that required the medication to be discontinued. Overall, these results suggest that aripiprazole may effectively reduce symptoms of ME/CFS and warrants further investigation in a randomized clinical trial. Exploring the mechanism of action for aripiprazole in neuroinflammatory conditions may also provide new insight into the pathogenesis of ME/CFS."

I'll keep an eye on the clinical trials register https://clinicaltrials.gov to see whether a trial is registered this year following the publication of this paper. If so, I'll tag it into the most relevant forums.

For a link to all registered ME/CFS studies -

ClinicalTrials.gov

clinicaltrials.gov

Abilify is used in patients who have ADHD when other medicines fail to work.
As many as 5% or even more or people with EDS/ME/CFS as many as 50% with EDS have ADHD underdiagnosed in a lot of them.

In the UK, waiting times for diagnosis could be as long as 1 to 2 years

 

[Daffodil123]

If you look up the effects of Abilify on the microbiome, it says it can target fungal biofilm. So maybe it helps those with overgrowth of fungal biofilm in the small intestine? Just a thought...

I think some of us have this.

 

[Aidan Walsh]

If you look up the effects of Abilify on the microbiome, it says it can target fungal biofilm. So maybe it helps those with overgrowth of fungal biofilm in the small intestine? Just a thought...

I think some of us have this.

I think a lot have ADHD combined with ME/CFS Adult or child onsets & very rarely diagnosed in ME/CFS. In EDS it takes years to find out they have this, they usually find out about it from other patients online, not from Doctors x x

 

[SarahJane]

I was one of the patients in this study.


I had been seeing Dr Bonilla since early 2020 and taking low dose abilify prescribed by him from February 2020 through February 2022. This was not a retrospective study. I started taking this medication under the impression it was an approved well studied treatment for ME/CFS. Immediately after the first month of taking it he started collecting scientific data / subjective patient reports from me on all of my symptoms. I know this because I recorded some of our appointment, including my 1 month follow up. The entire appointment was centered around the Abilify and data collection. Which I didn't understand at the time. I still have this recording.


These phone calls and data collection continued every two weeks to a month for the entire time I was on this medication. It was patient experimentation without informed consent. By the time this paper was published or maybe a month afterwards I was on roughly 2 mg a day and started having major cognitive decline, lapses and memory etc. he then continued the medication for another year getting me up to 4mg daily. Collecting data the whole time.

I got to the point where I was completely non-functional, bed bound with In-Home Care as a result of his experimentation. I did not know this was an experimental protocol. All of my memory and cognitive symptoms went away when I stopped it in 2022. It was horrific and cost me so much of my life. There were days that went by where I forgot half of what had happened. I got to the point where I would start to say something but couldn't remember what I said the previous sentence or where I was going with the conversation.

I thought that at least someone should know that nothing about this study was retrospective, at least in my case. It was labeled as retrospective to get through the red tape and consent requirements and protections that human research subjects would be afforded.

For me, it got so bad that his office staff labeled me as incapable of making medical decisions as a result of this experimental protocol. Had this an actual study in the traditional sense they obviously would have halted Aprilrizole treatment instead of escalating. However they continued to escalate for an additional year. Without me fully understanding what was going on.

Just wanted to let someone know. I don't know what the other patient's experience is were, but I know what mine was.

What he did and what Stanford did was highly unethical and illegal.

Disturbing FDA Loophole Allows Scientists To Do Experiments On Humans Without Informed Consent - ICAN - Informed Consent Action Network

An FDA rule change published in December 2023 solidifies that scientists are allowed to conduct human experiments without informed consent.

icandecide.org

I think you have grounds for a lawsuit. If I were you I’d find a pro bono lawyer for a consultation.

 

[konad2009]

Disturbing FDA Loophole Allows Scientists To Do Experiments On Humans Without Informed Consent - ICAN - Informed Consent Action Network

An FDA rule change published in December 2023 solidifies that scientists are allowed to conduct human experiments without informed consent.

icandecide.org

I think you have grounds for a lawsuit. If I were you I’d find a pro bono lawyer for a consultation.

I appreciate your recommendation. However, too much time has passed.

 

[SarahJane]

Do you mean actually legally?

 

[konad2009]

Do you mean actually legally?

Yes, I consulted with med-mal firm in California. I also contacted the institutional review board and Stanford. I've done all I can do.

 

[SarahJane]

Yes, I consulted with med-mal firm in California. I also contacted the institutional review board and Stanford. I've done all I can do.

I’m so sorry.

 

[Frangipani]

I have CFS and MDD. I was put on Abilify at the beginning of May to augment the anti-depressant that I was already taking. I noticed a difference right away in my energy and motivation. I started getting stuff done that had been on my to do list for ages. Now 6 weeks later, I'm feeling really "draggy" again. I have an appointment with my doctor to ask about increasing from 2 mg to 4 mg. However, after reading the post from the patient in the study, I'm not too sure if this is a good idea. Sure did enjoy how I felt for those 6 weeks though.

Just did some AI research. Since I'm taking it for depression it's safe to increase the dose. Using it to treat CFS is still off label and not recommended past 2 mg.

 

[konad2009]

I have CFS and MDD. I was put on Abilify at the beginning of May to augment the anti-depressant that I was already taking. I noticed a difference right away in my energy and motivation. I started getting stuff done that had been on my to do list for ages. Now 6 weeks later, I'm feeling really "draggy" again. I have an appointment with my doctor to ask about increasing from 2 mg to 4 mg. However, after reading the post from the patient in the study, I'm not too sure if this is a good idea. Sure did enjoy how I felt for those 6 weeks though.

Just did some AI research. Since I'm taking it for depression it's safe to increase the dose. Using it to treat CFS is still off label and not recommended past 2 mg.

At low doses Abilify supports dopamine activity, but as you approach 4 mg, it begins to downregulate it. This is a feature of the medication, not a bug. This is how it's intended to work at antipsychotic dosing levels. For ME/CFS, crossing that line can trigger severe cognitive side effects. When they increased my dose I experienced intense fatigue, major memory issues, and severe word-finding difficulties. Because you're balancing both MDD and ME/CFS, definitely watch out for those cognitive walls if you decide to change your dose. I hope it works for you.

 

[Frangipani]

At low doses Abilify supports dopamine activity, but as you approach 4 mg, it begins to downregulate it. This is a feature of the medication, not a bug. This is how it's intended to work at antipsychotic dosing levels. For ME/CFS, crossing that line can trigger severe cognitive side effects. When they increased my dose I experienced intense fatigue, major memory issues, and severe word-finding difficulties. Because you're balancing both MDD and ME/CFS, definitely watch out for those cognitive walls if you decide to change your dose. I hope it works for you.

Thanks for sharing your experience and knowledge. I will see what my doctor says and definitely proceed with caution.

 

[Daffodil123]

I think a lot have ADHD combined with ME/CFS Adult or child onsets & very rarely diagnosed in ME/CFS. In EDS it takes years to find out they have this, they usually find out about it from other patients online, not from Doctors x x

I personally think me/CFS and ADHD will turn out to have their root causes in bacterial imbalances in the gut microbiome, which directs brain development. EDS I do not know about that one.

 

[Aidan Walsh]

I personally think me/CFS and ADHD will turn out to have their root causes in bacterial imbalances in the gut microbiome, which directs brain development. EDS I do not know about that one.

My 23andMe health ancestry DNA RAW data shows I have 2 things going on, one is HFI Hereditary Fructose Intolerance, I am Homozygous to the most common European form, parents were both born in Southern Ireland for homozygous C/C rs1800546 & my results show I also have a Galactosemia nutation issues with cheese and milk. 2 illnesses

Maybe why we have gut biome issues?

I eat a lot of meat, fish, chicken, and turkey. Avoiding these foods with dairy, sugar, fructose, sorbitol, & lactose, I become bloated, sick, even numerous meds, vitamins are no good to me