What the trial was testing
The trial enrolled 380 patients with bipolar disorder. The study was sponsored by BioXcel Therapeutics Inc and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. 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
Agitation scores dropped 5.4 points more with the higher dose compared to placebo at 2 hours.
JAMA · 2022 · NCT04276883
These findings — that the higher dose reduced agitation significantly more than placebo within 2 hours — were published in the JAMA and represent the headline result of the study.
Researchers tracked outcomes across 380 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 bipolar disorder, 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 a large-scale study and the results were positive. In April 2022, the FDA approved this sublingual film (brand name Igalmi) specifically for acute agitation in adults with bipolar disorder or schizophrenia. If you experience severe agitation episodes, ask your doctor whether this fast-acting treatment might be appropriate 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 bipolar disorder trials
Greater Houston Area Pediatric Bipolar Registry
The purpose of this study is to perform a comprehensive research assessment of children and adolescents who meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for Bipolar Disorder (BD) , offspring of a parent with BD, and healthy controls (HC), to obtain blood samples and saliva samples from each subject to allow the evaluation for BD biomarkers and genetic information, to notify participants about future research studies they may qualify for , to recommend follow-up with an outpatient provider if needed and to use magnetic resonance imaging (MRI) (structural MRI and diffusion tensor imaging) to investigate brain structures and relevant pathways associated with mood and behavioral regulation, conversion from softer forms of the BD spectrum (BD-NOS) to harder forms (BD-I and BD-II) and possible early identification.
Exercise and Olanzapine-samidorphan
This is a single site trial in 30 patients with schizophrenia, schizoaffective, or bipolar I/II/NOS disorder in which all participants will receive eight weeks of olanzapine and samidorphan (Olz/Sam) plus four weeks of aerobic exercise.