A prospective clinical cohort study on pharmacological treatment of children with adhd – Identification of clinical, biological and objective factors associated with effect and side effects

Research problem and specific questions: The aim is to identify factors associated with efficacy and side effects of ADHD drugs; specifically, a) clinical characteristics (symptoms, comorbidity, etc.), b) genetic factors, and c) eye-tracking measures (eye movements, pupil dilation, and pupil reflex).In randomized controlled trials, >70% of children with ADHD get good symptom reduction, but only 30-40% in clinical cohorts.

There are few large prospective studies of clinically relevant cohorts.

Results regarding how different symptom profiles or other clinical characteristics affect the effect of ADHD drugs have so far been inconclusive. Neither have studies of how genetic factors affect treatment efficacy yielded uniform results. These have however been conducted on relatively small samples lacking clinical characterization.

Factors related to side effects are generally less studied.In ADHD, regulation of attention and brain arousal is deficient. Eye movements and pupil movements reflect attention and brain arousal respectively.

How these measures relate to ADHD drug effects has not been studied.Data and method: The project consists of 1) a clinical prospective observational study (n=638) with collected clinical data and DNA from children starting ADHD medication, and 2) a quasi-experimental pretest-posttest study (n≈150), with eye-tracking measurements before and 3 months after drug initiation.

In both cohorts, symptoms (hyperactivity, attention, etc.) and side effects (e.g. headache, weight change, palpitations) are followed up at 3 months.

These clinical cohorts are suitable for studying the project´s questions with regression analyses but are also suitable for machine learning techniques to identify more complex patterns.Societal relevance and utilization: In 2022, 8% of boys and 4.5% of girls between 10-17-years old in Sweden used ADHD drugs and the numbers are increasing.

At the same time, >50% stop treatment within 2-years.

The project aims to increase knowledge about what is the right targeted ADHD treatment, and thus efficient use of resources.Plan for project realization: This is a collaboration between researchers with different expertise and user representatives to ensure the best possible design of study protocols and analyses.

Data is collected within regular child and adolescent psychiatric care in close collaboration between clinics and academia. Funds are sought for data collection, support functions and salary funds for employees.