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Understanding Pediatric Depression and Overcoming Clinical Trial Hurdles

Shaping the future of adolescent mental health care

Upset adolescent boy sitting on sofa while his mother looks at his arm and comforts him with a hand on his shoulder

Adolescent mental health is an escalating concern both in the United States and around the world, and drug developers must be cognizant of common hurdles to overcome in pediatric depression clinical trials in order to deliver treatments to address this growing need. Depression among adolescents, age 12–18, manifests in various forms. Per the Diagnostic and Statistical Manual of Mental Disorders, to qualify for a diagnosis of major depressive disorder, one of the symptoms must be “depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feels sad, empty, hopeless) or observation made by others (e.g., appears tearful).” For adolescents, depression can also be characterized by an irritable mood. The daily lives of those affected can be severely disrupted, and the causes of adolescent depression can be complex — encompassing genetic predispositions, traumatic experiences, biological and chemical imbalances, social isolation, and other social factors.

Depression in adolescents differs from that in adults, and researchers often cannot address it in the same ways. Teens and children may respond differently to therapies in comparison to adults because their brains are still developing, and the underlying etiology of depression may be different. Recognizing the unique nature of adolescent brains is crucial when developing effective treatments for this age group. Tailored approaches in drug development and therapeutic interventions are the best way to address the specific needs of young people dealing with depression.

The notable increase in adolescent depression over the past decade underscores the urgent need for innovative solutions. Both anxiety and depression have surged; anxiety has risen across adolescent groups, while girls have been particularly affected by depression. Although it’s difficult to pinpoint a single cause for this rise, researchers have identified several potential causative factors that include:

  • Increased daily screen time
  • Social media being a major element of social interaction
  • COVID-19 and its widespread effects on the lives of adolescents

The COVID-19 pandemic has had a marked effect on the overall mental health of teens and children. Pediatric populations were already seeing a rise in depression and anxiety before the pandemic, and the isolation resulting from the shutdown seems to have compounded the issues. This contributed to the global increase of adolescent mental health disorders from 2020 to 2024, the causes of which are multifaceted.

One of the biggest contributors has been isolation from community support. Societal stress and isolation from peers have heavily impacted this age group, and the loss of in-person education and the associated school resources further exacerbated the situation. During this time, remote learning led to increased screen time, as screens were a necessity for both education and social interaction. Another contributor has been the grief and stress caused by family and community losses, or permanent disability, due to COVID-19 infections. Additionally, adolescents with challenging home environments had no reprieve, potentially increasing their exposure to traumatic events that can trigger mental health issues.

To combat the rise in adolescent depression, the drug development industry must prioritize developing treatments that are effective in teenagers. Treating depression in teens and children can help prevent lifelong mental health problems, thus improving the mental health of communities for years to come. However, there are few treatment options that are specific to adolescents with depression. There is also limited access to mental health treatment providers, which has resulted in a lack of access to care.

Without treatment, symptoms may worsen to the point where adolescents develop suicidal thoughts, which lead to more emergency room visits and hospital admissions, putting pressure on an already under-supported system. Adolescents are a vulnerable population, as they are managing many things at once, from developmental and identity changes to dealing with peer pressure and a lack of autonomy. Mental health issues that are left unaddressed can increase this vulnerability. With all of these elements in mind, it is clear that the industry needs to come together to develop new solutions for this population.

Overcoming potential issues in pediatric depression clinical trials

Clinical trials specific to adolescents with depression are needed now more than ever, but they come with a unique set of challenges that drug developers must overcome to be successful. The four most common challenges include:

1. Navigating regulatory complexity while minimizing cost

Data requirements for pediatric psychiatry trials can be incredibly complicated, and safety requirements for this population are more intricate than for adults, given that adolescents may be going through puberty and may still be undergoing growth and development. Success in this area of drug development requires expertise in global regulations and the ability to be flexible and well prepared. To reduce complexity and cost, drug developers need access to expertise in trial design tailored to this specific patient group. Sponsors must also understand how to navigate the differences between adolescent and adult depression trials and recognize that efficacy results from adult trials cannot be directly applied to adolescents. However, with the right experts on hand, sponsors can overcome these hurdles.

2. Enabling access to trials

It’s imperative to ensure that patients and doctors are aware of the existence of these trials. Drug developers must build trials around accessibility, taking into account the schedules of teens, including school, after-school activities and work hours. Scheduling with teens and children can be complex. If parents are unable to find caregivers for their other children, they will need to bring them to the site for visits. This could necessitate child care at sites, particularly when parents need to be present for the assessment. This is why it is critical to ensure that sites are well suited to the needs of this patient group. Decentralized and hybrid trials can increase accessibility for patients by offering more flexibility, allowing them to accommodate school and business hours. When patients don’t have to visit sites for every aspect of a trial, it becomes more approachable for them and their families.

3. Understanding the patient group and their needs

This population of patients is unique, with very specific considerations. Clinical trials in pediatric depression not only need to be tailored to pediatric populations, but also to patients with depression and mental health conditions. Drug administration and patient adherence to treatment can be particularly challenging in this group, and patients may also be taking multiple, ongoing medications while involved in the trial. Adolescents want to be in control of their lives but frequently need support to remember to take medicines or show up to appointments. Sponsors must also be sensitive to issues around assent in teenage patients, including drug/alcohol use, contraception or pregnancy. Additionally, teens need to receive communications in a way that makes sense to their lifestyles. For example, many adolescents prefer texts over phone calls when communicating important trial information. Taking the time to understand the day-to-day struggles of this patient group means employing the necessary expertise to do so.

4. Building relationships with caregivers and communities

There is often reticence in families, clinicians and communities to enrolling adolescents in depression clinical trials. Regulations require parental support for these trials, so getting them on board is essential. Parents may be wary of a trial for mental health disorders, and they may not be fully aware of how these trials can benefit their child. Education and community immersion are the keys to engaging families. When sponsors build strong relationships with community leaders, trusted clinicians and patient advocacy groups (PAGs), they gain a better understanding of the community, enhancing their ability to educate and recruit adolescents with mental health disorders.

The future of pediatric depression clinical trials

The importance of overcoming these clinical trial barriers cannot be understated, as adolescents with depression comprise a patient group in need of more solutions. New approaches and innovations are essential to advancing the field, including the development of novel administration methods, understanding new mechanisms of action, and promotion of a stronger industry-wide focus on prevention.

Prevention, in particular, is a crucial part of the future of adolescent depression solutions, aiming to reduce the incidence of depression before it starts. Strengthening crisis care systems is also critical to progress in this area, and an expansion in treatment options is an important element of these efforts. When drug developers have access to the resources needed to address the most common problems in pediatric depression clinical trials, it benefits a population that is much in need while improving the health of our communities.

Advancing the field with the right partner

Creating solutions that reduce adolescent depression requires experts in complex clinical trials. When sponsors partner with providers of contract research organization (CRO) solutions that have the knowledge needed to address the challenges in this field, they are setting themselves up for success. The PPD™ clinical research business of Thermo Fisher Scientific has a depth and breadth of knowledge when it comes to developing solutions to complex problems. Our end-to-end solutions enable seamless integration throughout the drug development process. We also have a global reach, with sites and experts all around the world, ready to serve sponsors where needed. Our teams have expertise in everything from complex trial design, regulatory requirements, risk mitigation and site selection, to patient recruitment and retention. With a focus on decreasing the trial burden on the patient and their family, our capabilities provide the necessary support for psychiatric clinical trials.

Our Rare Disease and Pediatric Center of Excellence is dedicated to addressing the complex issues inherent to pediatric trials. Over the past five years, our team has conducted more than 325 pediatric studies involving more than 160,000 patients with access to 12,600 sites. We have 29 board-certified pediatricians on staff, including two pediatric psychiatrists. Our neurology and psychiatry services are robust, with 39 psych and neurobehavioral studies completed in the past five years, involving more than 3,295 patients across approximately 1,000 global sites. Additionally, we have 160 owned and partnered clinical research sites. We know the importance of community education, and we place a strong emphasis on our relationships with PAGs, leveraging an established network to facilitate outreach.

By selecting a dedicated CRO partner, sponsors are able to support this vulnerable population by delivering crucial therapeutic innovations to adolescents in need.

Set your adolescent psychiatric clinical trial up for success with the right partner.

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