PR: Stardots, Karolinska Institutet and Uppsala University initiate the HARMONI clinical study in women’s mental health

HARMONI will evaluate whether Psilmi® can identify objective neuro-ocular and biological response patterns associated with hormone sensitivity, PMDD and ADHD.

Uppsala, Sweden, September 2, 2026. Stardots AB today announced the site initiation of the HARMONI clinical study at Uppsala University and Uppsala University Hospital. The Site Initiation Visit marks an important operational milestone ahead of participant recruitment and clinical data collection.

HARMONI stands for Hormone-Associated Responses and Multi-Omics in Neuropsychiatric Investigation.

The name reflects the study’s ambition to combine physiological measurements from the nervous system with hormonal, molecular and clinical information to investigate hormone sensitivity in women.

The exploratory clinical study is being conducted in collaboration with Karolinska Institutet and Uppsala University. Professor Helena Kopp Kallner is the coordinating investigator, and Professor Inger Sundström Poromaa is the principal investigator at the Uppsala study site.

HARMONI will evaluate Psilmi®, Stardots’ investigational neuro-ocular measurement platform, as a potential new method for identifying objective physiological patterns associated with premenstrual dysphoric disorder, PMDD, ADHD and hormone sensitivity.

Investigating objective signals associated with PMDD

PMDD is a severe hormone-related mood disorder that can significantly affect mental health, relationships, education, working life and overall quality of life.

Despite its impact, recognition can be delayed and many affected women experience barriers to appropriate care. Current assessment relies heavily on symptoms recorded prospectively across multiple menstrual cycles. While this is important for identifying the cyclical pattern of symptoms, the process can be time-consuming and dependent on consistent self-reporting.

HARMONI will investigate whether hormone sensitivity is also reflected in objective physiological patterns.

The study will integrate several complementary sources of information, including:

Eye movements and pupil responses

Controlled visual, cognitive and auditory stimulation

Hormonal and molecular information from blood samples

EEG measurements in a subset of participants

Prospective symptom ratings and clinical information

Approximately 250 participants are planned across groups representing PMDD, ADHD, combined PMDD and ADHD, and healthy controls.

The study design will enable the researchers to investigate both condition-associated patterns and biological dimensions that may extend across traditional diagnostic categories.

Psilmi as an objective measurement platform

HARMONI will use Psilmi®, Stardots’ investigational neuro-ocular measurement platform.

Psilmi combines structured visual and cognitive stimuli with high-precision eye tracking and pupillometry. The platform captures responses such as pupil dynamics, fixations, saccades and other time-resolved ocular signals.

Advanced computational methods are used to transform these signals into multidimensional biomarker profiles intended to support research into nervous-system regulation and clinically relevant biological variation.

In HARMONI, researchers will evaluate whether these neuro-ocular signals, combined with hormonal, molecular and clinical information, can contribute to the identification of hormone sensitivity associated with PMDD and ADHD.

Psilmi is currently an investigational platform used for research and evaluation. It is not currently cleared as a medical device and is not intended at this stage to provide an independent clinical diagnosis.

A potential new measurement layer for women’s health

If successful, HARMONI could represent an important step towards more standardized and biologically informed assessment of hormone-related mental health conditions.

The long-term clinical opportunity is to complement symptom-based assessment with objective and reproducible physiological information.

Such an approach could potentially support clinicians in evaluating complex presentations, help researchers characterize biological variation within patient populations, and provide new tools for measuring response in clinical studies.

A validated measurement approach could ultimately contribute to:

• More efficient and informed clinical assessment
• Shorter patient pathways and fewer repeated healthcare contacts
• Improved identification and stratification of participants in clinical trials
• More objective measurement of treatment engagement and response
• New research and development opportunities in women’s health, neuroscience and pharmaceutical development

These potential applications remain to be clinically demonstrated. HARMONI is designed to generate the evidence needed to evaluate whether Psilmi can provide reliable and clinically relevant information in this area.

“Clinical validation is where technology begins its journey towards healthcare impact. We believe Psilmi has the potential to add an objective measurement layer to areas of medicine that still depend heavily on subjective symptom reporting.

If the HARMONI study is successful, the opportunity extends beyond a new method for assessing a single condition. It could create value for patients, clinicians, healthcare systems, researchers and companies developing new treatments in women’s health and neuroscience. HARMONI will help us build the clinical evidence needed to evaluate that opportunity carefully and rigorously.”

Daniel Petrini, CEO of Stardots

The Site Initiation Visit at Uppsala University Hospital focused on ensuring that the clinical research team, technology, study procedures and operational workflow are aligned before recruitment and data collection begin.

About HARMONI

HARMONI, Hormone-Associated Responses and Multi-Omics in Neuropsychiatric Investigation, is an exploratory, prospective clinical study investigating biomarkers of hormone sensitivity in women with PMDD, ADHD, combined PMDD and ADHD, and healthy controls.

The study combines neuro-ocular measurements with hormonal, molecular, EEG and clinical information. It is conducted in collaboration between Stardots, Karolinska Institutet and Uppsala University, with clinical study activities at Danderyd Hospital and Uppsala University Hospital.

About Psilmi®

Psilmi is Stardots’ investigational software platform for objective, stimulus-driven neuro-ocular measurement.

The platform uses controlled visual and cognitive stimuli, eye tracking and pupillometry to capture physiological signals associated with nervous-system regulation. Advanced computational models transform these signals into multidimensional biomarker profiles for research into psychiatric and neurodevelopmental conditions.

Psilmi is currently intended for research and evaluation and is not a cleared medical device.

About Stardots

Stardots is a Swedish medical technology company developing objective digital biomarkers and computational tools for neurology, psychiatry and precision medicine.

The company’s technology platforms use eye tracking, movement analysis, physiological modelling and advanced data analysis to support clinical research, treatment development and the future delivery of more objective and individualized healthcare.

For further information

Daniel Petrini

CEO, Stardots AB

Email: daniel.petrini@stardots.se

Phone: +46 707 82 7001

Website: www.stardots.se