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
Evaluation of Efficiency of One Day Patient/Caregiver Psychoeducation on the Caregiver's Burden
Bipolar disorder (BD) has a huge impact on the lives of patient and their relatives. Psychoeducation programs on BD has been shown to be effective on the burden of patients and their caregivers. However, actual programs appear to be incompatible with patients obligations and services requirements of the service. The development of "minute" programs (in one day) is justified.
Healthy Lifestyles in Bipolar Disorder: Bay Area Study
The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.