By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience
With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. In a mental health disorder laden with patient enrollment barriers due to the indication’s symptoms, as well as many situational and social factors, how does a sponsor ensure their drug development program enrolls an adequate number of participants in a timely manner? Understanding the patient journey can provide you with insights needed to tailor your program to succeed.
The Patient Journey
The patient journey of someone living with depression is multi-faceted and personal, characterized by a complex interplay of psychological and social experiences. While each individual’s journey is unique, here are some common stages that many people may encounter:
- Depression Onset
The patient experiences symptoms like persistent feelings of sadness, hopelessness, or emptiness, as well as changes in appetite, sleep patterns, motivation, and energy levels. These symptoms will likely negatively impact the patient’s friends, family, and overall quality of life. Due to these symptoms, this stage may be long-lasting. - Seeking Help
This stage may be difficult to reach, as the patient must acknowledge they need help and request it.
- May be precipitated by friends, family, or a physician referring the patient
- Could come after a previous event like losing a job, presenting symptoms at an annual wellness visit, or more serious events like attempting to take one’s own life
- Ideally, the patient seeks help from a healthcare professional able to provide services or refer them for support
- Diagnosis
A medical professional screens and diagnoses a patient with depression, preferably using a validated assessment methodology (e.g., DSM-5 or other standard depression clinical outcome assessment).
- Treatment
Treatment can take various forms, including therapy, medication, a combination of both, or a clinical trial. It’s typical to try different doses and treatments before identifying the best match for the patient. The symptoms may also impact the effects of treatment, as treatment success will depend on the patient’s ability to engage with and stay consistent with the medication.
Clinical trials are often only considered if the provider suggests them as an option. They may sometimes be used as the first-line treatment, but equally likely, clinical trials are offered when other treatments fail to work, or the patient’s depression becomes treatment-resistant depression (TRD).
- Disease Management
The patient and their providers will need to manage relapses and setbacks to depression, adjusting treatments as necessary. The hope is for patients to achieve recovery or stabilize symptom management in some way.
What Are the Barriers to Enrolling Depression Clinical Trials?
One common symptom of depression is a pervasive lack of motivation. This sense of apathy and disinterest can extend to all aspects of life, making the decision to seek treatment appear as an insurmountable hurdle. If an individual does choose to get help, the idea of committing to a treatment plan presents its own set of challenges, such as adhering to the plan, attending therapy sessions, and implementing lifestyle changes. The lack of follow-through in treatment can impede participation in clinical trials and impact the reliability of study outcomes.
Other barriers that affect enrollment in depression clinical trials include:
- Lack of awareness: Many individuals may not be familiar with ongoing clinical trials or the opportunities they present for accessing novel therapies.
- The stigma surrounding mental health: Despite progress in raising awareness about mental health conditions, stigma still persists. This fear of judgment or discrimination may prevent individuals from openly discussing their struggles or seeking help through clinical trials.
- Underdiagnosis in men: Depression is often underdiagnosed and undertreated in men due to several reasons, including societal expectations of “traditional masculinity” contributing to stigmatization, downplaying or ignoring symptoms, and reluctance to discuss symptoms.
- Disparities in access to healthcare: Access to healthcare facilities, including those conducting clinical trials, can be limited for individuals, particularly in underserved communities. This lack of access may be due to geographical barriers, financial constraints, or a shortage of mental health resources.
- Logistical challenges: Logistical factors such as transportation to study sites and scheduling conflicts with work can pose considerable obstacles to participation.
How to Overcome Enrollment Barriers in Depression Clinical Trials
Understanding the patient journey of individuals living with depression is crucial in overcoming these barriers to clinical trial participation. By recognizing the unique challenges that they face and tailoring strategies to address their needs, sponsors can foster a supportive environment that encourages participation and engagement. Here are a few other ways to support enrollment:
- Education and Outreach
Education plays a vital role in raising awareness about depression clinical trials and dispelling misconceptions surrounding mental health research. Providing accessible and accurate information about the purpose, benefits, and process of clinical trials can empower individuals to make informed decisions about participation.
Outreach efforts should utilize diverse communication channels, including online platforms, community events, and healthcare providers, to reach individuals from various backgrounds and ensure the information is accessible to all. - Partnerships with Patient Advocacy Organizations
Collaborating with patient advocacy organizations can provide valuable insights into the lived experiences of individuals with depression and help sponsors tailor their outreach and engagement efforts accordingly. These organizations support patients and carers through education, care access, and trial navigation, which can positively impact patient recruitment. By working closely with advocacy groups, sponsors can ensure that their research efforts are informed by the perspectives and priorities of the patient community. - Community Engagement
Through community engagement, sponsors can provide information on study design and the science of the IP. Being an engaged community partner also allows the sponsor to have an empathetic and patient-centric approach, positioning the sponsor as a trusted partner and the study as a viable treatment option to be recommended to potential participants. - Patient-Centric Approaches
Adopting patient-centric approaches that prioritize the needs and preferences of individuals with depression is essential in overcoming barriers to enrollment and a priority of regulatory agencies. These approaches involve designing study protocols that accommodate the challenges and limitations experienced by participants, such as flexible scheduling options, remote monitoring capabilities, clinically relevant outcome assessments, and personalized support services. - Communication
Communication plays a pivotal role in engaging individuals with depression in clinical trials. It’s important to use language that is sensitive, empathetic, and free of judgment to cultivate a welcoming and supportive environment for participants. - Cultural Sensitivity
Since depression clinical trials are often global in nature, spanning several cultures, languages, and healthcare landscapes, it’s essential to recognize and respect the cultural diversity of participants.
Cultural sensitivity involves understanding and addressing cultural norms, beliefs, and practices that may influence an individual’s attitude toward mental health and research participation. By tailoring recruitment materials, outreach strategies, and study protocols to reflect the cultural context of the target populations, sponsors can overcome cultural barriers and enhance the diversity of clinical trial participation.
Explore Worldwide’s Experience with Depression Clinical Trials
At Worldwide Clinical Trials, we recognize the importance of addressing depression through innovative research. Our neuroscience capabilities offer end-to-end services to support the development of novel treatments for depression and other mental health conditions. If you’re interested in leveraging our capabilities and partnering with us to advance research in depression, we invite you to contact our team.
Together, we can continue breaking down enrollment barriers and enhancing treatment outcomes, thereby improving the lives of individuals affected by this complex mental health condition.
