Dr Torous is a Clinical Fellow in Psychiatry at Harvard Medical School and Senior Resident at the Harvard Longwood Psychiatry Residency Training Program in Boston. He is the Digital Psychiatry Editor for Psychiatric Times. Twitter: @JohnTorousMD. Dr. Keshavan is Stanley Cobb Professor of Psychiatry at Beth Israel Deaconess Medical Center in Boston.

The FDA recently approved a new formulation of aripiprazole that includes an ingestible digital sensor that can record when the medication was taken by sending a signal to a wearable patch.1 This medication, Abilify MyCite, is now approved for use in schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for depression in adults.

Some have questioned whether an ingestible medication that sends digital signals regarding adherence is appropriate for use in disorders like schizophrenia. Concerns that Abilify MyCite may increase paranoia and delusions have been raised. However, while concern for patient welfare is well intentioned, it may be more appropriate to consider what the evidence reveals about technology use and schizophrenia.

Two years ago, our team worked with the National Alliance of Mental Illness (NAMI) to conduct a survey of over 400 individuals with schizophrenia and their use of digital technologies. We found that these patients were not only open to using technology but using it did not induce or trigger paranoia or delusions.2 We also reviewed all the published literature on smartphones and monitoring for schizophrenia last year and did not identify a single case of harm.3

Coincidently, we worked with a patient with schizophrenia who invited his own method to track how aripiprazole reduced the number of auditory hallucinations he experienced.4 This individual used a digital tally counter to record real-time hallucinations and discovered that tracking was useful for keeping him engaged with treatment. While only a single case, it does demonstrate that some patients with schizophrenia are extremely interested in innovative approaches to their medications and want to try new tools. It would be wrong to deny them this opportunity because others have concerns that may or may not apply.

Rather, it is encouraging to see the introduction of new tools and innovations for psychiatric disorders. Schizophrenia and related disorders impact ~1.5% of the population, and in the US, the economic burden of schizophrenia is greater than $60 billion per year.5 While antipsychotic medications (eg, aripiprazole), can be effective for reducing symptoms and helping patients recover, adverse effects can be difficult for some to tolerate. Stopping antipsychotic medications is the leading cause of relapse in schizophrenia, and while Abilify MyCite is not FDA-approved for improving adherence, the potential is there.

For the appropriate patients, it is possible to imagine how this digital pill could help them with medication, monitor progress, and share results their family and psychiatrists. And if the Abilify MyCite system detects when a patient has stopped taking the medication, that may be a window to have a conversation about adverse effects or other issues. A quick discussion here could prevent a relapse that can be stressful to patients and their families as well as expensive to the health care system. Of course, some patients may not want to use such a system and could easily take off the wearable patch.

That said, we all must be careful in this new world of digital psychiatry. Looking at the mobile app space, the lack of consumer privacy protections for apps that record personal health information like medications and even sensor data (such as real-time location) is concerning.6 By carefully claiming not to be medical devices, companies that produces these apps live outside of FDA and federal privacy protections, and thus are able to engage in questionable data collection practices. Outside the scope of health care, there may be a literal need for paternalism (and materialism) after the FBI issued a warning in summer 2017 of numerous cyber security risks that included recording children’s conversations and selling families’ personal data.7

There are real privacy risks today-right now Abilify MyCite is taking the right steps to mitigate potential harm through regulation and research. Like any new medication, Abilify MyCite will only become well adopted if it can demonstrate that it is effective in the real world. While its ability to track ingestion is novel and raises concerns, it also presents an opportunity to improve outcomes for patients with schizophrenia and related disorders.

Disclosures:

Dr Torous is a Clinical Fellow in Psychiatry at Harvard Medical School and Senior Resident at the Harvard Longwood Psychiatry Residency Training Program in Boston. He is the Digital Psychiatry Editor for Psychiatric Times. Twitter: @JohnTorousMD. Dr. Keshavan is Stanley Cobb Professor of Psychiatry, Beth Israel Deaconess Medical Center in Boston.

References:

1. US Food and Drug Administration. FDA approves pill with sensor that digitally tracks if patients have ingested their medication. November 13, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm.

2. Gay K, Torous J, Joseph A, Pandya A, Duckworth K. Digital Technology Use Among Individuals with Schizophrenia: Results of an Online Survey. JMIR Ment Health. 2016;3(2):e15

3. Torous J, Firth J, Mueller N, Onnela JP, Baker JT. Methodology and Reporting of Mobile Heath and Smartphone Application Studies for Schizophrenia. Harv Rev Psychiatry. 2017;25:146-154.

4.Torous J, Roux S. Patient-Driven Innovation for Mobile Mental Health Technology: Case Report of Symptom Tracking in Schizophrenia. JMIR Ment Health. 2017 Jul;4(3).

5. Marcus SC, Olfson M. Outpatient antipsychotic treatment and inpatient costs of schizophrenia. Schizophr Bull. 2008;34:173–180.

6. FBI. Consumer Notice: Internet-Connected Toys Could Present Privacy and Contact Concerns for Children. July 17, 2017. https://www.ic3.gov/media/2017/170717.aspx.

7. Torous J, Roberts LW. Needed innovation in digital health and smartphone applications for mental health: transparency and trust. JAMA Psychiatry. 2017;;74:437-438.