A new pill that needs to be taken just once a week could change how patients with schizophrenia manage their condition.
The star-shaped capsule gradually releases medication from inside the stomach, maintaining steady drug levels while eliminating the daily pill burden that often leads to missed doses. Clinical trial results published in Lancet Psychiatry show the weekly treatment controlled symptoms just as effectively as daily medication, potentially addressing one of the biggest challenges in schizophrenia care: getting patients to take their medicine consistently.
How the Star-Shaped Technology Works
The capsule starts about the size of a multivitamin. Once swallowed, it expands into a six-armed star shape that’s too large to exit the stomach. Each arm slowly releases risperidone—a widely prescribed antipsychotic medication—over the course of a week.
“We’ve converted something that has to be taken once a day to once a week, orally, using a technology that can be adapted for a variety of medications,” explains Giovanni Traverso, an MIT associate professor who helped develop the device. “The ability to provide a sustained level of drug for a prolonged period, in an easy-to-administer system, makes it easier to ensure patients are receiving their medication.”
After about seven days, the arms naturally break apart and exit through the digestive system. The technology took more than a decade to develop, starting in Traverso’s lab before being refined by MIT spinout company Lyndra Therapeutics.
Trial Results Show Promise
The phase 3 trial enrolled 83 patients across five U.S. sites, though only 45 completed the full five-week study. Researchers found that blood levels of the medication stayed within optimal ranges throughout the week, with less variation than typically seen with daily pills.
Using the standard Positive and Negative Syndrome Scale, patients’ symptoms remained stable throughout the study period. Side effects were minimal—some participants experienced mild acid reflux and constipation early on, but these didn’t persist.
What makes these results particularly encouraging? The trial included a diverse group of participants: 75% were male, 81% were Black or African American, with an average age of 49 years. This demographic representation matters because schizophrenia affects people across all backgrounds, yet clinical trials don’t always reflect this diversity.
Why Weekly Dosing Matters
For people with schizophrenia, remembering to take medication daily can be extremely challenging. The condition itself can impair memory and decision-making abilities. When patients miss doses, symptoms often worsen, leading to potential hospitalization.
“One of the biggest obstacles in the care of people with chronic illnesses in general is that medications are not taken consistently,” notes Leslie Citrome, the study’s lead author and a clinical professor at New York Medical College. “This leads to worsening symptoms, and in the case of schizophrenia, potential relapse and hospitalization.”
Current alternatives to daily pills include injectable medications given every two weeks to two months. But these require healthcare provider visits and aren’t always acceptable to patients who prefer oral medications.
The Adherence Challenge
Why did researchers focus specifically on schizophrenia for this technology? As Traverso explains: “One of the areas of unmet need that was recognized early on is neuropsychiatric conditions, where the illness can limit or impair one’s ability to remember to take their medication.”
The weekly approach offers something unique: the convenience of oral medication without the daily adherence burden. Patients get a sharp increase in drug levels on dosing day, followed by a controlled decline over the week—all staying within therapeutic ranges.
Key Trial Findings:
- Blood drug levels remained stable and effective throughout each week
- Symptom control matched that of daily medication
- Only 47 of 83 enrolled patients completed the full study
- Minimal side effects that didn’t persist beyond early treatment
- Less variation in drug levels compared to daily dosing
What’s Next?
The researchers plan larger phase 3 studies before seeking FDA approval for this risperidone delivery method. They’re also preparing trials for other medications, including contraceptives.
“This really demonstrates that what we had hypothesized a decade ago, which is that a single capsule providing a drug depot within the GI tract could be possible,” Traverso reflects. The results show the capsule achieved predicted drug levels and controlled symptoms in a substantial group of patients.
The technology represents more than just a scheduling convenience. For patients struggling with severe mental illness, consistent medication adherence can mean the difference between stability and crisis. A weekly pill that removes the daily decision-making burden could significantly improve outcomes.
Having oral medication options that ensure consistent dosing might also reduce the stigma some patients feel about injectable treatments. “Having the option to take medication by mouth once a week represents an important option that can assist with adherence for the many patients who would prefer oral medications versus injectable formulations,” Citrome emphasizes.
As Robert Langer, MIT’s David H. Koch Institute Professor and Lyndra co-founder, puts it: “We are delighted that this technology which started at MIT has reached the point of phase 3 clinical trials.”
The journey from laboratory concept to potential treatment option illustrates how addressing seemingly simple problems—like remembering to take daily medication—can require sophisticated engineering solutions. For millions of people with schizophrenia worldwide, that engineering might soon translate into better, more manageable care.
Related
If our reporting has informed or inspired you, please consider making a donation. Every contribution, no matter the size, empowers us to continue delivering accurate, engaging, and trustworthy science and medical news. Independent journalism requires time, effort, and resources—your support ensures we can keep uncovering the stories that matter most to you.
Join us in making knowledge accessible and impactful. Thank you for standing with us!
