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
Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups
Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes. Evidence supports a complex network between psychosocial factors and glycaemic control that can be highly variable between persons. It is assumed that subgroups exist that show different trajectories of glycaemia and mental health. Belonging to a particular subgroup may be linked with a higher risk of developing mental health problems compared to others. This suggests that it is possible to treat individuals in different subgroups in a manner that optimizes their treatment and can improve health outcomes. Accurate characterisation can inform more individualized care. This calls for a more personalised approach considering the idiosyncrasies of different subgroups. Over 3 years, the investigators have established the basis of a precision mental health approach for diabetes using n-of-1 analyses. By utilizing combined ecological momentary assessment (EMA: repeated daily sampling of psychosocial factors in everyday life) and continuous glucose monitoring (CGM), intensive longitudinal data per person could be collected. This enables the analysis of individual associations between glycaemic parameters and psychosocial variables and identification of individual sources of diabetes distress in each person. The objective of the present study is to use of the n-of-1 approach to identify subgroups of PWD who share common characteristics in the associations between glucose and psychosocial variables. The identified subgroups shall be used to develop a digital twin for precision mental health in diabetes. The digital twin serves as representation of a real person, allowing to make simulations and predictions of the course of mental health and glycaemia. These predictions can inform diabetes care and lead to more precise, personalised treatment decisions. To achieve this, a longitudinal panel including over 1,400 PWD who continuously complete EMA and questionnaire surveys and measure glucose levels using CGM was developed. Over 1000 clinical interviews to diagnose mental disorders have been conducted to identify major mental health conditions and map mental outcomes. To identify subgroups and develop the digital twin, the sampling will be expanded aiming at a total of 1,809 PWD. Incidence and remission of mental disorders will be determined via repeated interviews. The complex networks between clinical, metabolic, and psychosocial data will be analysed using machine learning, leading to new insights with the potential to shape future guidelines. These results will be used by the digital twin to predict courses of glycaemic control and mental health, translating the individual evidence into direct treatment suggestions.
Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
This study aims to explore how six short, 15-minute self-regulation techniques affect the body and brain in a female adult with ADHD and stabilized bipolar disorder. The techniques being tested include: * Aerobic exercise * Controlled breathing (cyclic sighing) * Aromatherapy with lavender essential oil * Listening to specific music (Solfeggio 528 Hz) * Virtual reality relaxation with forest imagery * Emotional Freedom Technique (EFT) tapping One session of quiet sitting with eyes open serves as a comparison. The participant will attend one 15-minute session per week for each technique. Before and after each session, the researchers will measure: * Heart rate and heart rate variability * Stress levels using Subjective Units of Distress Scale * Mood using a questionnaire * Blood pressure * Brain activity using EEG * Memory performance with a simple test (N-back) * Pain sensitivity The goal is to understand how these short, non-invasive techniques influence both physiological and psychological responses. Sessions are safe, short, and designed to involve minimal risk. The findings may help guide future research on relaxation and exercise strategies for people with ADHD and bipolar disorder.