What the trial was testing
The trial enrolled 182 patients with schizophrenia. The study was sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
KarXT reduced schizophrenia symptoms nearly twice as much as the sugar pill after 5 weeks.
The New England journal of medicine · 2021 · NCT03697252
These findings — that karXT reduced symptoms on the standard schizophrenia scale significantly more than the sugar pill — were published in the The New England journal of medicine and represent the headline result of the study.
Researchers tracked outcomes across 182 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with schizophrenia, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was an initial testing study and KarXT was not yet FDA-approved at the time. However, in September 2024, the FDA approved KarXT (brand name Cobenfy) for adults with schizophrenia. Talk to your doctor about whether this newly available treatment might be right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open schizophrenia trials
Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia
The purpose of this study is to provide an effective repetitive transcranial magnetic stimulation (rTMS) treatment for depressive symptoms in patients with schizophrenia. Schizophrenia patients with depressive symptoms will be exposed to rTMS to improve their symptoms.
A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia