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

Population Study Finds Strong Association Between Assisted Reproductive Technologies and Offspring ADHD

Taiwanese Nationwide Population Study Finds Strong Association Between Assisted Reproductive Technologies and Offspring ADHD

Background: 

Since the first in vitro fertilization (IVF) in 1978, assisted reproductive technology (ART) has led to over 10 million births worldwide.  

There are four types of embryo transfers, depending on whether they are fresh or frozen, and on their developmental stage. 

Fresh cleavage stage embryos are transferred on day 2 or 3 following fertilization and typically contain four to eight relatively large, undifferentiated cells. Fresh blastocyst embryos are transferred on day 5 or 6 after fertilization. At this point, they have developed over a hundred cells and have differentiated into two types: the inner cell mass, which develops into the fetus, and the outer cell layer, which forms the placenta. 

Globally, more children are now born through assisted reproductive technology using frozen-thawed embryo transfer than fresh embryo transfer.  

Research suggests that ART-conceived offspring may face increased risks of cardiovascular, musculoskeletal, chromosomal, urogenital diseases, and cancers. Might they also be at increased risk for ADHD? 

Study:

Taiwan’s single-payer health insurance covers over 99% of people and records all their healthcare activity. Since 1998, it has kept an ART database for all couples registered for IVF treatment. 

A Taiwanese research team reviewed all records for the five-year period from 2013 through 2017, ultimately analyzing 3,125 live singleton births from fresh cleavage stages, 1,332 from fresh blastocysts, 1,465 from frozen cleavage stages, and 4,708 from frozen blastocysts, alongside 878,643 naturally conceived singleton births. 

The team controlled for the following potential confounders: pregnancy-induced hypertension, chronic hypertension, diabetes mellitus, gestational diabetes mellitus, unhealthy lifestyle, placenta previa, placenta abruption, preterm premature rupture of membrane, and postpartum hemorrhage. 

Results:

With these adjustments, cleavage stage embryo transfers, whether fresh or frozen, were associated with a seven-fold higher rate of ADHD diagnosis in offspring than natural conception. 

Frozen blastocyst embryo transfers were likewise linked to a seven-fold increase in ADHD diagnoses in offspring compared to natural conception. Notably, fresh blastocyst transfers showed a 19-fold increase, likely due to the smaller number of cases in this category. 

The team concluded, “Compared to natural conception, ART is associated with higher risks, particularly for preterm birth, ADHD, and developmental delay.” 

Conclusion: 

This large national cohort suggests that ART-conceived singletons face higher rates of several adverse outcomes, including preterm birth, ADHD, and developmental delay. Clinicians and prospective parents should therefore weigh these potential associations when counseling and planning care, prioritize optimized ART protocols and perinatal management, and ensure early developmental surveillance for ART-conceived children so concerns can be identified and addressed promptly.

It is important to note that the findings also point to the likely contribution of underlying parental infertility in these developmental outcomes. Future research should aim to disentangle parental- versus procedure-related risks to clarify absolute risk magnitudes. As always, associations of this time should not be interpreted as causal due to the inability of observational studies to rule out all possible confounding factors.

October 1, 2025

Why Do So Many Young People Miss an ADHD Diagnosis? Insights from a New Study

Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most common neurodevelopmental conditions, yet many young people, especially girls, receive a diagnosis late or not at all. This matters, because a delayed diagnosis often means missed opportunities for support, treatment, and improved long-term outcomes. A recent study by Barclay and colleagues (2024) sheds new light on why ADHD recognition is inconsistent, and what we can do about it.

The Study:

Researchers analyzed data from nearly 10,000 children in the UK Millennium Cohort Study. They compared children whose ADHD was recognized early (ages 5–7), later (ages 11–14), or not recognized at all, despite evidence of symptoms. The team also looked at differences between boys and girls to better understand why diagnosis patterns vary by sex.

Key Findings:
  1. Severity Drives Earlier Recognition
    Children who were diagnosed at a younger age often had more visible difficulties: emotional outbursts, peer conflict, conduct issues, and lower cognitive scores. In other words, the “louder” and more disruptive the symptoms, the more likely ADHD was flagged early.

  2. “Quieter” ADHD May Be Overlooked
    Children with stronger prosocial skills or higher cognitive ability were less likely to be recognized, even if they had clear ADHD symptoms. These children may be able to “mask” their difficulties, or adults may misinterpret their struggles as personality quirks rather than signs of ADHD.

  3. Emotional Dysregulation Matters
    Emotional dysregulation—big swings in mood, difficulty calming down, intense frustration—was strongly linked to recognized ADHD in boys, but not in girls. This suggests that clinicians may pay closer attention to these behaviors in boys, while overlooking them in girls.

  4. Co-occurring Conditions Can Influence Diagnosis
    Children with autism were more likely to have their ADHD identified. On the flip side, those who engaged in more physical activity were slightly less likely to be recognized, though the reasons for this are not yet clear.

What This Means for Clinicians:

The study highlights the importance of looking beyond the “classic” hyperactive child stereotype when considering ADHD. Clinicians should:

  • Pay attention to symptoms of emotional dysregulation, even if they are not part of standard diagnostic checklists.

  • Consider ADHD in children with good grades or strong social skills if other symptoms are present.

  • Be mindful of gender differences, since girls may be more likely to internalize symptoms or present with inattentiveness rather than hyperactivity.

What This Means for Parents and Patients:

If you’re a parent, it’s important to trust your observations. If your child struggles with focus, organization, or emotional regulation—even if they are doing well academically or socially—these could still be signs of ADHD. Advocating for an evaluation can make a big difference.

Moving Forward

This study makes clear that ADHD is not one-size-fits-all. Recognition often depends on how symptoms show up, how disruptive they appear, and even the child’s gender. By broadening our awareness and refining our screening practices, we can ensure that fewer children slip through the cracks and more receive the support they need early in life.

September 30, 2025

ADHD Medication and Academic Achievement: What Do We Really Know?

Parents and teachers often ask: Does ADHD medication actually improve grades and school performance? The answer is: yes, but with important limitations. Medications are very effective at reducing inattention, hyperactivity, and impulsivity but their impact on long-term academic outcomes like grades and test scores is not as consistent.

In the Classroom

The medications for ADHD consistently: Improve attention, reduce classroom disruptions, increase time spent on-task and help children complete more schoolwork and homework. Medication can help children with ADHD access learning by improving the conditions for paying attention and persisting with work.

Does Medication Improve Test Scores and Grades?

This is where the picture gets more complicated.  Medications have  stronger effect on how much work is completed but a weaker effect on accuracy. Many studies show that children on medication attempt more problems in reading, math, and spelling, but the number of correct answers doesn’t always improve as much. Some studies find small but significant improvements in national exam scores and higher education entrance tests during periods when children with ADHD are medicated.

Grades improve, as well, but modestly. Large registry studies in Sweden show that students who consistently take medication earn higher grades than those who don’t. However, these gains usually do not close the achievement gap with peers who do not have ADHD.

Keep in mind that small improvements for a group as a whole mean that some children are benefiting greatly from medication and others not at all.  We have no way of predicting which children will improve and which do not. 

Medication Alone Isn’t Enough

Academic success depends on more than just reducing inattention, hyperactivity and impulsivity. Skills like organization, planning, studying, and managing long-term projects are also critical.  Medication cannot teach these skills.

So, in addition to medication, the patient's treatment program should include educational support (tutoring, structured study skills programs), behavioral interventions (parent training, classroom management strategies), and accommodations at school (extra time, reduced distractions, organizational aids) Parents should discuss with their prescriber which of these methods would be appropriate.

Conclusions 

ADHD medication is a powerful tool for reducing symptoms and supporting learning. It improves test scores and grades for some children, especially when taken consistently. But it is not a magic bullet for academic success. The best results come when medication is combined with educational and behavioral supports that help children build the skills they need to thrive in school and beyond.

September 17, 2025