DelRicht Research is pleased to highlight the strong performance of our site teams in a Phase 4 clinical trial focused on major depressive disorder (MDD) in adults aged 18-65. Over an 18-month enrollment period, our network surpassed expectations, delivering results that underscore DelRicht’s ability to execute complex psychiatric trials with precision and care.

This study required thoughtful patient education, consistent engagement, and careful management of trial procedures that could be particularly challenging for individuals living with depression. By combining operational efficiency with compassionate support, DelRicht delivered measurable results that advanced the study’s objectives.

Exceeding Enrollment Goals

The sponsor’s national enrollment target was 350 participants across 40 U.S. sites. DelRicht’s site at Touro Medical Center in New Orleans, led by Dr. Patrick Dennis, was expected to enroll nine participants. By the close of enrollment, the team had successfully enrolled 14 participants, 160% of the goal.

In addition to surpassing its enrollment target, Dr. Dennis’ site was recognized for its leadership during start-up. The site achieved first site activation across the study and screened the second participant overall, demonstrating DelRicht’s ability to move quickly from award to execution while engaging participants at the earliest stages.

These results highlight the operational readiness and accurate feasibility assessments that allow DelRicht sites to consistently perform at a high level.

Addressing Trial Challenges with Targeted Solutions

This study presented multiple challenges that required proactive strategies.

Maintaining daily diary compliance
Participants were required to complete paper diaries throughout the study. For individuals managing the symptoms of depression, sustaining consistent compliance represented a significant burden and potential risk to data integrity.

Mitigating placebo response during the open-label phase
The study design included a 10-week open-label period, followed by a 26-week double-blind extension. Ensuring participants were appropriately prepared for the responder assessment was critical to avoid inflated placebo response rates that could undermine study validity.

To address these challenges, DelRicht implemented two core strategies:

Proactive coaching and participant support: Coordinators monitored diary completion closely and provided ongoing encouragement to participants, reinforcing the importance of compliance while offering practical solutions for daily barriers. Regular check-ins helped participants feel supported while also sustaining accurate data collection.

Structured placebo response training: Study teams guided participants through tailored education that clarified the purpose of assessments, helped them understand symptom reporting, and reduced the likelihood of inflated placebo effects. This training contributed to cleaner data and more reliable outcomes during the double-blind extension.

These approaches exemplify DelRicht’s commitment to both participant well-being and scientific rigor, ensuring that challenges did not compromise trial success.

Building Trust, Delivering Results

The success of this trial was grounded in the leadership of Dr. Patrick Dennis and the trusted reputation of Touro Medical Center in the New Orleans community. Patients felt confident engaging in a study environment where they were heard, supported, and guided through every step of the process.

This foundation of trust, paired with DelRicht’s centralized operational support, positioned the site to exceed expectations while maintaining strong compliance and high-quality data. For sponsors and CROs, this outcome reinforced the value of working with a network capable of managing both the logistical and emotional complexities of psychiatric trials.

What This Means for Sponsors and CROs

This trial underscores several advantages that DelRicht offers in psychiatric research:

– Effective participant coaching and engagement to sustain compliance even in studies with daily self-reporting requirements.
– Proven processes for mitigating placebo response, strengthening data quality in sensitive psychiatric protocols.
– Operational speed and accuracy, demonstrated through first site activation, early patient screening, and above-target enrollment performance.

Together, these differentiators reflect DelRicht’s ability to navigate the unique demands of psychiatric trials while consistently exceeding sponsor expectations.

Partner With Us

At DelRicht Research, we recognize that psychiatric studies demand both operational precision and compassionate approaches. Our investigators and site teams are equipped to manage the complexities of mental health trials, from daily compliance requirements to long-term patient engagement.

Whether in psychiatry or across our nine therapeutic areas, DelRicht’s embedded site model ensures results that sponsors can rely on.

To learn more about our capabilities or to explore partnership opportunities, visit www.DelRichtResearch.com.