Enhancing Signal Detection and Mitigating Placebo Response in Major Depressive Disorder Clinical Trials

Placebo response remains one of the most significant challenges in Major Depressive Disorder (MDD) clinical trials, often obscuring actual treatment effects and delaying the approval of promising new therapies. Despite its widespread recognition, the placebo effect remains poorly understood. It refers to a measurable improvement in a participant’s condition following an inactive treatment and is particularly impactful in psychiatric trials where clinician-administered outcomes are central to study success. The subjective nature of these assessments, combined with rater variability and participant expectations, makes MDD trials especially vulnerable to elevated placebo response rates and inconsistent outcome signal detection.

This webinar is designed to help attendees improve the quality, reliability and interpretability of clinician-rated outcomes in MDD trials. Participants will gain foundational knowledge of the placebo effect, its origins, mechanisms and relevance to current trial design, while exploring modern, evidence-based strategies to minimize its impact. Through a combination of expert guidance, real-world case examples and practical tools, the session will focus on strengthening rater performance, reducing data variability and improving trial signal detection.

Training Objectives:

• Explore methods to mitigate placebo response via rater-focused education and calibration, structured interview guides and specialized mitigation training
• Examine central monitoring approaches, including algorithmic and data-based review, and risk-based expert analysis
• Understand centralized rating and scoring models using trained clinicians
• Identify best practices for managing participant expectations
• Learn how eCOA design can prevent common rater errors before they impact data

Register for this webinar to learn practical signal detection approaches that reduce placebo response and improve clinician-rated outcomes in MDD clinical trials.

Speakers

Luka Lucić, PhD, Senior Director, Clinical Science, Psychiatry, Cogstate

Dr. Luka Lucić specializes in the administration of psychiatric scales (e.g., PANSS, MADRS, CDRS-R and HAM-D) in support of global biopharmaceutical projects. Dr. Lucić has more than 10 years of experience serving as a Scientific Lead and Lead Trainer on global clinical trials, primarily directing and supporting the training of investigators engaged in international research programs in psychiatry, neurodevelopment and rare & orphan disorders. He provides protocol consultation and develops rater-training curricula across various modalities, ranging from didactic modules to applied rater performance training for raters and clinicians.

Dr. Lucić applies his scientific research to develop optimized data analytics services tailored to the specific needs of unique clinical trials. Training approaches adopted by Dr. Lucić have minimized the time raters spend in training while utilizing contemporary educational curricula to maximize the knowledge gained.

Dr. Lucić is an Associate Professor in the Department of Social Science and Cultural Studies at the Pratt Institute in Brooklyn, New York. Dr. Lucić received his PhD in Developmental Psychology from The City University of New York (CUNY).

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Svenja Wacker, PhD, Neuropsychology Science Director, Cogstate

Dr. Svenja Wacker is a licensed Clinical Neuropsychologist specializing in business development for global clinical trials, bridging cognitive science and business strategy, collaborating with pharmaceutical and biotech companies to optimize trial strategy, implement innovative assessment solutions optimized for trial strategy and improve the delivery of clinical and diagnostic tools for CNS diseases.

Dr. Wacker’s clinical trial activities are grounded in a solid foundation of hands-on clinical work. She has provided neuropsychological assessments and interventions to patients with CNS diseases and injuries and to their families to guide them toward resilience and empowerment. This clinical expertise informs her strategic approach to clinical trials, ensuring that patient-centric and scientifically rigorous solutions are integrated across all phases of research.

Dr. Wacker holds a PhD in Clinical Psychology from George Mason University and completed a Clinical Neuropsychology Fellowship at Yale University School of Medicine. She further honed her skills through a postdoctoral residency in Neuropsychological Assessment at Harvard Medical School.

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