January 14, 2025

NEW STUDY: Understanding the Gap Between ADHD Clinical Trials and Real-World Patients

Background 

ADHD (Attention-Deficit/Hyperactivity Disorder) is one of the most studied neurodevelopmental conditions, with many clinical trials evaluating the effectiveness and safety of various medications. These trials, known as randomized controlled trials (RCTs), are considered the gold standard for assessing treatments. However, strict eligibility criteria often exclude many real-world patients, raising questions about whether the findings from these trials apply to everyday clinical settings.

Our latest study sheds light on this issue, revealing just how many individuals with ADHD might be excluded from RCTs and the impact this exclusion has on their treatment outcomes. 

Method

Researchers used Swedish national registries to analyze data from 189,699 individuals diagnosed with ADHD who started medication between 2007 and 2019. They applied exclusion criteria from 164 international RCTs to identify who would have been considered ineligible for these trials in order to determine the proportion of individuals with ADHD who would not meet the eligibility criteria for RCTs.  

Key Findings

Many Patients Are Ineligible for Clinical Trials:

  • Over half (53%) of the study population would have been ineligible for ADHD medication trials.
  • Adults were most likely to be excluded (74%), followed by adolescents (35%) and children (21%).

Ineligible Patients Face Unique Challenges:

  • Treatment Switching: Ineligible individuals were more likely to switch medications within the first year (14% higher likelihood compared to eligible patients).
  • Medication Discontinuation: They were slightly less likely to stop taking their medication during the first year.

Higher Risk of Adverse Outcomes:

  • Ineligible patients experienced significantly higher rates of psychiatric hospitalizations and health issues such as depression, anxiety, and substance use disorders. For instance:
    • Psychiatric hospitalizations: Nearly 10 times more likely.
    • Specialist visits for substance use disorders: About 15 times more likely.
    • Anxiety-related visits: Over 11 times more likely.

What This Means

These findings highlight a major gap between the controlled environments of clinical trials and the realities faced by individuals with ADHD in everyday life. While RCTs provide valuable insights, their restrictive criteria often exclude patients with more complex health profiles or co-existing conditions. This limits the generalisability of trial results, meaning that treatment guidelines based solely on RCTs may not fully address the needs of all patients.

Conclusion

This study demonstrated that a significant proportion of individuals with ADHD, particularly adults, do not meet the eligibility criteria for standard RCTs. These results emphasize the importance of bridging the gap between research settings and real-world applications. By recognizing and addressing the limitations of RCTs, we can work towards more equitable and effective ADHD treatment strategies for everyone.

Garcia-Argibay M, Chang Z, Brikell I, Kuja-Halkola R, D'Onofrio BM, Lichtenstein P, Newcorn JH, Faraone SV, Larsson H, Cortese S. Evaluating ADHD medication trial representativeness: a Swedish population-based study comparing hypothetically trial-eligible and trial-ineligible individuals. Lancet Psychiatry. 2025 Jan 6:S2215-0366(24)00396-1. doi: 10.1016/S2215-0366(24)00396-1. Epub ahead of print. PMID: 39788146.

Related posts

New Global Estimate of Adult ADHD Prevalence: A Comprehensive Review

Adult ADHD has long been a subject of debate in the field of mental health, with previous estimates of its prevalence varying widely. To achieve a more precise understanding, an international team of researchers conducted a new umbrella review and meta-analysis, offering an updated estimate of adult ADHD rates worldwide.

A Comprehensive Approach: Reviewing 57 Studies

This large-scale analysis combined five systematic reviews and meta-analyses, incorporating data from 57 unique primary studies. Altogether, the research synthesized findings from a pooled total of over 21 million participants. This comprehensive approach provided a more accurate estimate of the global prevalence of ADHD in adults.

Key Findings: 3.1% Global Prevalence

The study concluded that the worldwide prevalence of adult ADHD is 3.1%, with a 95% confidence interval ranging from 2.6% to 3.6%. This estimate falls within the range of earlier reports but provides a more targeted understanding of the rate at which ADHD affects adults globally.

Putting the Numbers in Context

The researchers described this prevalence rate as “relatively high.” They noted that it is only slightly lower than the estimated prevalence of major mental health conditions like schizophrenia (4%) and major depressive disorder (5%)—disorders that have historically received significant attention and resources worldwide.

Moreover, the prevalence of adult ADHD is higher than that of several other well-known mental health conditions, including bipolar disorder (1%), as well as anxiety disorders such as PTSD (Post-Traumatic Stress Disorder), OCD (Obsessive-Compulsive Disorder), GAD (Generalized Anxiety Disorder), and panic disorders.

Implications for Awareness and Treatment

This updated estimate emphasizes that ADHD is a significant global mental health concern in adults, comparable to or exceeding the prevalence of other disorders that are often more widely recognized. These findings underscore the need for greater awareness, research, and treatment options for adult ADHD, which is still frequently misunderstood or overlooked in the broader discourse of mental health.

Conclusion

By providing a clearer picture of how prevalent ADHD is in adult populations around the world, this study contributes valuable data that could shape future research, policy, and clinical approaches.

November 8, 2024

NEWS TUESDAY: A Retrospective Study on Post–COVID-19 Mental Health Distress in 13 Million Youth

NEWS TUESDAY: A Retrospective Study on Post–COVID-19 Mental Health Distress in 13 Million Youth

Our research team conducted a study, published in the Journal of the American Academy of Child & Adolescent Psychiatry, to understand how COVID-19 (SARS-CoV-2) affects the mental health of young people. We used a method called Kaplan-Meier survival analysis to figure out how likely kids were to develop new mental health problems, including suicidal thoughts, within two years after being infected. We looked at medical records of 7.5 million children and 5.3 million teenagers who were part of the TriNetX Research Network. Importantly, we focused only on those who didn’t have any mental health issues before.

Of these young people, almost 300,000 children and over 220,000 teens had tested positive for COVID-19. The results were significant: children who had COVID-19 had a 15% chance of being diagnosed with a new mental health condition, compared to just 2.6% for children who didn’t get COVID-19. For teens, the chance was 19% for those infected and 5% for those not infected.

We found that the risk of developing new mental health issues was six times higher in children and four times higher in teens who had COVID-19. This shows that younger kids are more strongly affected.

The study also highlighted that COVID-19 was linked to higher rates of various mental health problems, especially in children. This means it’s really important to screen for mental health issues in young people after they’ve had COVID-19, particularly for those who had severe cases.

Overall, our findings point to the need for special support for kids and teens who may be more vulnerable after the pandemic. It’s clear that the mental health effects of COVID-19 go beyond just physical health, and it’s crucial that doctors and policymakers include mental health care in plans to help young people recover.

September 24, 2024

Does ADHD Medication Improve the Parenting Skills of Adults with ADHD?

Does ADHD Medication Improve the Parenting Skills of Adults with ADHD?

Raising children is not easy. I should know.

As a clinical psychologist, I've helped parents learn the skills they need to be better parents. And my experience raising three children confirmed my clinical experience.

Parenting is a tough job under the best of circumstances, but it is even harder if the parent has ADHD.

For example, an effective parent establishes rules and enforces them systematically. This requires attention to detail, self-control, and good organizational skills. Given these requirements, it is easy to see how ADHD symptoms interfere with parenting. These observations have led some of my colleagues to test the theory that treating ADHD adults with medication would improve their parenting skills. I know about two studies that tested this idea.

In 2008, Dr. Chronis-Toscano and colleagues published a study using a sustained-release form of methylphenidate for mothers with ADHD. As expected, the medication decreased their symptoms of inattention and hyperactivity/impulsivity. The medication also reduced the mother's use of inconsistent discipline and corporal punishment and improved their monitoring and supervision of their children.

In a 2014 study, Waxmonsky and colleagues observed ADHD adults and their children in a laboratory setting once when the adults were off medication and once when they were on medication. They used the same sustained-release form of amphetamine for all the patients. As expected, the medications reduced ADHD symptoms in the parents. This laboratory study is especially informative because the researchers made objective ratings of parent-child interactions, rather than relying on the parents' reports of those interactions. Twenty parents completed the study. The medication led to less negative talk and commands and more praise by parents. It also reduced negative and inappropriate behaviors in their children.

Both studies suggest that treating ADHD adults with medication will improve their parenting skills. That is good news. But they also found that not all parenting behaviors improved. That makes sense. Parenting is a skill that must be learned. Because ADHD interferes with learning, parents with the disorder need time to learn these skills. Medication can eliminate some of the worst behaviors, but doctors should also provide adjunct behavioral or cognitive-behavioral therapies that could help ADHD parents learn parenting skills and achieve their full potential as parents.

May 7, 2021

Swedish Nationwide Population Study: Newborn Seizures Double Risk of ADHD

The first few weeks of life are the time when babies are most vulnerable to seizures (known as neonatal seizures). This is partly because of events that can occur during birth, and partly because the newborn brain is naturally in a more excitable state than a mature brain, making it more prone to seizure activity. 

Seizures affect roughly 1 to 3 in every 1,000 full-term babies born, and the rate is considerably higher in premature babies, at around 11 to 14 per 1,000. In most cases, seizures at this age are triggered by a specific event or injury affecting the brain. In full-term newborns, the most common cause is a condition called hypoxic-ischemic encephalopathy (HIE), which occurs when the brain is deprived of adequate oxygen and blood flow around the time of birth. Other causes include genetic or metabolic conditions, stroke, bleeding in the brain, and structural abnormalities in how the brain developed. In very premature babies, bleeding into the fluid-filled spaces of the brain (known as intraventricular hemorrhage) is the leading culprit. 

Diagnosing seizures in newborns is tricky because many normal or abnormal movements and behaviors in this age group can look like seizures without actually being them. For this reason, monitoring the baby’s brain activity using an electroencephalogram (EEG) – a test that records electrical signals in the brain – is essential to confirm whether a seizure is truly occurring. 

Sweden’s single-payer health system provides universal coverage, with national registers linking healthcare and population data. Researchers tracked infants with EEG/aEEG-confirmed seizures born between 2009 and 2020 and compared them to controls without neonatal seizures. 

Altogether, 1062 infants with neonatal seizures were matched with 5310 controls. 

The team adjusted for birth, mode of delivery, sex, birth weight, and Apgar scores – quick, standardized assessments used to evaluate newborns’ health minutes after birth. 

With these adjustments, infants who had neonatal seizures were twice as likely to subsequently be diagnosed with ADHD and three times as likely to be subsequently diagnosed with autism spectrum disorder.  

The authors emphasized that because the study was observational, it cannot demonstrate a direct cause-and-effect relationship between neonatal seizures and outcomes. Factors like seizure frequency, genetics, and socioeconomic status are thought to significantly impact the prognosis of affected children, but these could not be included in this study due to data limitations. 

March 18, 2026

Meta-analysis Finds Small to Moderate Benefits of Single Exercise Sessions for Adult ADHD

Background: 

There are currently few long-term treatment options for adult ADHD. Psychostimulants can help reduce symptoms, but their benefits rely on availability, continued use, and are not easily tolerated by some. Cognitive-behavioral therapies have also proven to be helpful, but access is limited because they must be provided by trained specialists. These challenges highlight the need to explore alternative interventions that could provide cognitive and behavioral improvements with fewer side effects. 

Exercise has shown potential as a nonclinical intervention for ADHD. Previous research indicates that physical activity can increase cortical volume, enhance brain activation, and boost connectivity in cognitive regions, as well as raise dopamine and norepinephrine levels – effects similar to psychostimulants. Research in children and teens with ADHD has found that both regular exercise programs and even single workout sessions can improve executive functions (mental skills like planning and self-control) and reduce core ADHD symptoms. But whether exercise helps adults with ADHD has remained an open question. 

Study:

A Chinese sports medicine research team set out to answer this by reviewing all available peer-reviewed studies on exercise and adult ADHD. They found so few studies on regular exercise programs – only four total, and three of those were small pilot studies just testing whether the approach was feasible – that they couldn’t draw firm conclusions about long-term exercise interventions. 

However, they were able to analyze four moderate-to-high-quality studies involving 152 adults with ADHD that tested single exercise sessions. The combined results showed moderate improvements in inhibitory control (the ability to resist impulses and stay focused). Adults not taking medication showed large improvements.  

When they looked at four studies involving 170 adults, they found small but consistent improvements in core ADHD symptoms after single exercise sessions. There was little to no variation (heterogeneity) in individual study outcomes, and no sign of publication bias. 

Results:

The team concluded, “Overall, these findings offer preliminary evidence on the potential role of exercise as a helpful strategy in the management of adult ADHD,” but cautioned that more well-designed randomized controlled trials are needed to determine the efficacy of both acute and chronic exercise interventions for adult ADHD, with particular emphasis placed on determining the best “prescription” for exercise – what type, how intense, and how often. 

They also noted that most existing research has focused narrowly on attention and impulse control, while other important mental abilities like working memory and mental flexibility remain largely unexplored. 

Take-Away

The takeaway here is practical and accessible: you don't need a long-term fitness program to get a cognitive bump from exercise if you have ADHD. Even a single session appears to help — particularly with impulse control. While the research base is still thin and we don't yet know the ideal exercise "prescription," the risk-benefit calculation is hard to argue with. For adults with ADHD who can't access medication or therapy, or who simply want an additional tool, breaking a sweat may be worth building into the routine.

Meta-analysis Finds People with ADHD Twice as Likely to Self-harm

Background: 

Non-suicidal self-injury (NSSI) means intentionally hurting yourself without trying to end your life. Common examples include cutting, scratching, or burning yourself. This behavior is most common in teenagers, affecting 13-20% of adolescents. It’s also called self-harm or deliberate self-injury. 

Young people who struggle with managing emotions, act impulsively, or have mental health conditions like depression are more likely to self-harm. 

Because ADHD involves impulsivity and often occurs alongside emotional difficulties, researchers have suspected a link between ADHD and self-injury. However, previous studies have tended to be small, unrepresentative, and inconsistent, making it hard to draw clear conclusions. 

The Study: 

Researchers combined results from 14 different studies involving nearly 30,000 people to get a clearer picture. They looked at children, teenagers, and adults with ADHD from various settings—including hospitals, community programs, and general population studies. 

To be included, studies had to confirm ADHD diagnosis through professional evaluation or validated testing methods. 

Key findings 

  • About 1 in 4 people with ADHD (27%) have engaged in self-injury. This rate was similar for adults (25%) and teenagers (28%).
  • People with ADHD had more than twice the odds (2.25 times higher) of self-injury compared to people without ADHD 
  • Girls and women with ADHD were at highest risk—they had four times higher rates of self-injury than boys and men with ADHD 

Conclusion: 

The researchers concluded that roughly one in four people with ADHD have engaged in non-suicidal self-harm. The findings suggest that ADHD and self-harm share overlapping vulnerabilities. 

Overall, this meta-analysis strengthens evidence that people with ADHD face a significantly elevated risk of non-suicidal self-injury, likely reflecting overlapping challenges with impulsivity, emotional regulation, and co-occurring mental health conditions. Importantly, this does not mean self-harm is inevitable in ADHD. It does, however, highlight the need for early screening, supportive environments, and targeted mental-health care to help reduce risk and support healthier coping strategies.

March 5, 2026