Research & Development
Disciplined Science, Thoughtful Design, Confident Execution
Advancing psychedelic medicine is complex, but the fundamentals remain clear. How we evaluate progress is just as important as the results themselves.
Pioneering evidence-based approaches to psychedelic medicine
We implement carefully designed and methodologically sound study conditions that generate meaningful, interpretable results.
We are currently conducting four Phase 3 trials, studying LSD for anxiety and depression without adjunct psychotherapeutic interventions.
Addressing the complexities of R&D in psychedelics
Our decision to focus on the broad MDD and GAD indications is intentional. These disorders represent two of the largest patient populations in psychiatry. This is especially critical given the high burden these disorders impose across patients and the extent to which patients have been underserved by existing therapies. For indications where most patients are failed by currently available drugs, we believe all patients deserve better.
In psychedelic research, “functional unblinding,” or the process by which the perceivable effects of a drug allow participants to accurately guess whether they received the drug or a placebo, is a frequently discussed topic. In reality, this is not unique to psychedelics. Psychiatric medications modulate pathways in the brain and most produce noticeable effects, including sedation, stimulation, or perceptual changes.
Our studies adhere to the established gold standard method. One of these methods is the use of an inert placebo as the comparator in primary statistical analyses of our pivotal trials. We believe this remains the only scientifically appropriate comparator in psychiatry, regardless of a drug’s mechanism of action. We preserve the blind in other ways to reinforce the rigor of the studies through multiple safeguards, including blinded central raters, consistent controls across studies, and thoughtful participant education designed to minimize bias and ensure reliable, interpretable results.
We apply an intentional treatment framework in our studies that includes a high-granularity assessment of participants’ experience and perceptual changes throughout the course of a dosing session. This includes detailed documentation of dosing session monitor interventions and item-level tracking of perceptual effects that may necessitate support.
Our Phase 3 studies incorporate structured, hour-by-hour characterization of the resolution of transient drug effects, beginning at hour 5 post-dose through hour 8, which is the fixed minimum monitoring period. This approach enables a precise definition of time-to-resolution and a clear, consistent patient experience.
Employee Stories
“We address the complexities of clinical trials directly by implementing well-structured study conditions that yield clear, reliable results. Our trial design emphasizes safety and robust evidence generation, placing actionable data, intuitive assessment tools, and informed clinical judgment at the core.”
“At Definium, putting the more than 50 million people living with GAD and MDD and their loved ones at the center of everything we do is a core value that our team prioritizes every day. This is what drives our work, fosters collaboration, and helps us stay focused on making a difference.”
“At Definium, quality assurance isn’t a checkpoint; it’s embedded in how we build, think, and collaborate. We work cross-functionally, communicate openly, and stay tightly aligned with the development team to move fast and smart. I’m honored to be a part of an organization that is at the forefront of mental health innovation and doing it with a patient-first mindset.”
Partner with us
For healthcare professionals interested in partnering with us to advance our efforts as we forge a new era of psychiatry, contact our Medical Affairs team.
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