Driving 467% Enrollment in a Phase 3 MDD Trial
Driving 467% Enrollment in a Phase 3 MDD Trial
DelRicht Research is proud to share the remarkable performance of our site team in a Phase 3 clinical trial investigating therapies for major depressive disorder (MDD) in adults ages 18-65. Within a condensed eight-month enrollment window, our site reached its target but achieved more than four times the expected number of participants, demonstrating DelRicht’s strength in rapid activation and high-impact recruitment.
This trial posed unique challenges, from narrow eligibility requirements to strict patient compliance expectations. By pairing targeted outreach with patient-centered education and consistent follow-up, DelRicht was able to deliver results that made a meaningful contribution to the overall success of the study.
Enrollment Outcomes That Exceeded Every Expectation
The sponsor’s plan called for 300 participants across 50 sites in the United States. DelRicht’s New Orleans site at Touro Medical Center, led by Dr. Patrick Dennis, was asked to contribute six participants. By the close of enrollment, the site had enrolled 28 participants, 467% of the original goal, ranking among the strongest performers in the trial.
Equally significant was the pace of activation. The New Orleans site was ready to enroll within 64 days of award, a timeline that reflects both DelRicht’s start-up efficiency and its commitment to operational speed. These outcomes showcase DelRicht’s ability to pair rapid readiness with high-volume recruitment, even in trials with demanding inclusion and exclusion criteria.
Overcoming Barriers to Participation
Executing this study required addressing several significant hurdles:
– Highly selective eligibility requirements
Participants with psychiatric comorbidities were excluded, and only those with stable psychotherapy use were eligible. This narrowed the potential participant pool substantially.
– Medication and cannabis restrictions
Use of antidepressants outside of specified criteria and medicinal cannabis disqualified otherwise interested patients, creating additional screening challenges.
– Daily paper PROs
The protocol required consistent completion of paper-based patient-reported outcomes (PROs), a task that could be burdensome and easy to miss without support.
To manage these complexities, DelRicht applied a multi-layered strategy:
– Extended outreach and referral efforts ensured that eligible patients were identified quickly, drawing on physician networks and community ties to reach the right population.
– Patient education sessions prepared participants for the requirements of the study, setting clear expectations around medication restrictions and the importance of daily PRO compliance.
– Daily follow-up and support from coordinators kept participants on track with diary completion and sustained overall engagement throughout the trial.
Together, these measures transformed what could have been enrollment and compliance roadblocks into opportunities for sustained participant success.
Leadership, Trust, and Performance
The leadership of Dr. Patrick Dennis was central to this success. With deep ties to the New Orleans community, Dr. Dennis and his team created an environment of trust where patients felt confident and supported. This trust, combined with DelRicht’s structured operational backing, allowed the site to consistently exceed expectations while maintaining compliance and data quality.
Sponsors and CROs benefitted from both the speed of activation and the sheer scale of enrollment at the site, outcomes that reflect the unique capabilities of DelRicht’s embedded site model.
Key Takeaways for Sponsors and CROs
The performance of this Phase 3 trial highlights several capabilities that DelRicht brings to high-barrier psychiatric research:
– Exceptional enrollment delivery, with results far surpassing goals even under restrictive eligibility criteria.
– Operational agility, demonstrated through rapid start-up timelines and early activation.
– Robust patient engagement systems, ensuring daily compliance with paper-based reporting and sustained trial participation.
These elements reinforce DelRicht’s ability to contribute meaningfully to complex psychiatric studies, providing both enrollment strength and high-quality data integrity.
A Partner for High-Barrier Trials
At DelRicht Research, we understand that trials in psychiatry require sensitivity, education, and consistency. Our embedded site model and community-driven approach enable us to deliver results that sponsors can rely on, even in the most selective studies.
To learn more about how DelRicht can support your psychiatric development programs, visit www.DelRichtResearch.com or connect with us directly to explore partnership opportunities.
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