This month, Click Therapeutics announced that the FDA has cleared Motivista, a smartphone-based prescription digital therapeutic for the negative symptoms of schizophrenia. It is the first prescription digital therapeutic cleared for schizophrenia, and the company calls it the first authorized treatment for negative symptoms. For families like mine, that is not a small headline.
Why negative symptoms matter so much
When most people picture schizophrenia, they picture hallucinations and delusions. Medication can often quiet those. What it usually does not touch are the negative symptoms: the loss of motivation, the flatness, the pulling away from friends and the things a person used to love. In my own family, medication helped, but the negative symptoms remained. They are often what keeps someone from working, from finishing school, from simply calling a friend back. And until now, clinicians have had no FDA-authorized treatment aimed squarely at them.
Motivista is used alongside antipsychotic medication and outpatient care, for adults whose positive symptoms are stable. In the phase 3 CONVOKE trial, people using it for 16 weeks improved by 6.8 points on a standard negative-symptom scale, compared with 4.2 points for a digital control app. That is a modest effect, and it should be described honestly as one. Participants spent about an hour a week in the app, roughly the time of a therapy session, and most kept using it through the study.
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Modest is not the same as minor. For a symptom domain that has had nothing, a real, measurable improvement matters.
Clearance is not the same as access
Here is what worries me. FDA clearance answers one question: Does this work well enough to be authorized? It does not answer the questions that decide whether a family will ever see it.
Will insurers pay? The company has not announced a price, and it is openly making the case that “payers and state Medicaid programs should want to cover” it. Many people living with schizophrenia rely on Medicaid. If state programs do not cover prescription digital therapeutics, Motivista will reach the people who need it least.
Will prescribers know it exists? A psychiatrist who has never written a prescription for software needs to learn how, and a patient’s family needs to know it is worth asking about.
Will it still exist in three years? That is not a rhetorical question. As I have written before, half of mental health apps vanish within three years. Pear Therapeutics, which brought some of the first prescription digital therapeutics to market, filed for bankruptcy in 2023. FOCUS, a well-studied smartphone program for people with serious mental illness developed at Dartmouth, was discontinued after its funding was cut. Strong evidence did not guarantee survival in either case. A business model did, or did not.
What it can and cannot do
Families should also understand the limits. Motivista is not a replacement for medication or therapy. It is not meant for someone in crisis or whose positive symptoms are not under control. And it cannot alert a prescriber if something goes wrong. It treats one part of the illness, between appointments, and that is exactly where a tool like this can help.
What needs to happen next
Payers, including state Medicaid programs, should set clear coverage pathways for FDA-cleared digital therapeutics, not leave each family to fight a denial on its own. Health systems should make prescribing one as routine as prescribing a medication. Clinicians should know this option exists, and when it is the right fit.
And families should ask. If your loved one with schizophrenia is stable on medication but still struggling with motivation and withdrawal, ask the psychiatrist whether Motivista is appropriate.
The science got us here. Whether this becomes a treatment people actually receive is now up to the rest of us.
Nicole Drapeau Gillen is a mother, advocate, and author who translates the fast-moving landscape of technology in serious mental illness (SMI) care into guidance families and clinicians can use. Thrust into caregiving for a loved one with SMI, with no direction on how to help, she turned that experience into a mission, writing two books and building an ongoing effort to bring families and clinicians into the conversation.
Her first book, Schizophrenia and Related Disorders: A Handbook for Caregivers, is a reference for every stage of caregiving, endorsed by Dr. E. Fuller Torrey as a must-read for SMI caregivers. Her second, Connected Care: A Practical Guide to Technology for Serious Mental Illness, maps apps, artificial intelligence tools, telepsychiatry, and brain-based treatments for a field moving faster than anyone can track. Dr. Akira Sawa, director of the Johns Hopkins Schizophrenia Center, has said the book “directly addresses” significant gaps.
