December 2025’s studies add practical detail to a shift already underway: psychedelic care is moving from “can it work” to “how do we deliver it safely, consistently, and in a way payers can cover.” The month’s findings matter for clinics building staffing models, for health systems setting safety standards, and for investors tracking what will scale in real settings rather than controlled trials.
Real-World Data and the European Path to Scale
A Swiss real-world retrospective study in treatment-resistant depression (n=19) reported large symptom reductions after psilocybin at 20–35 mg, but with response and remission rates around 22–33%, below what many controlled trials have reported. That gap is operationally important: real clinics see broader case-mix, more variable support outside the dosing day, and less uniform follow-up. If you are building a service line, assume meaningful benefit for a subset of patients, plan for non-responders, and budget for structured preparation and post-session visits rather than treating the dosing day as the whole intervention.
A separate European review makes the scaling constraint explicit: regulatory approval is not the finish line in Europe because each country still requires a health technology assessment, and psychedelic packages are hard to evaluate when they combine a drug with psychotherapy and have limited head-to-head comparisons against existing care.
European systems should not wait for US pathways to settle; they need local evidence plans, outcome sets that align with payer questions, and service models that comply with national payment rules. Delphi’s EU Lead, Floris Wolswijk, has documented these requirements and workable options in detail in the Reimbursement Pathways for Psychedelic Therapies report.
Cross-Diagnosis Signals and Protocol Design
In a compassionate-use retrospective study of patients treated for depressive or anxiety disorders (n=30), LSD at 100–200 mcg produced a delayed but sustained heart rate increase peaking around 3–4 hours, while psilocybin at 15–30 mg showed an earlier decline; the study reported no serious cardiovascular adverse events. Clinics can convert that into concrete protocols: set observation windows and vital-sign cadence that match each compound’s time course, decide when medical coverage must be on-site versus on-call, and document thresholds for escalation so staff act quickly and consistently.
Cross-diagnosis work continues to show that the “therapy platform” matters as much as the diagnosis label. MDMA-assisted therapy, first developed for PTSD, illustrates this clearly: extended sessions, high-touch preparation, and structured integration drive the model’s staffing and cost profile, and that operational template now informs how programs think about other indications. December’s qualitative sub-study nested in a Phase II psilocybin PTSD trial (n=21) adds a clinical takeaway: participants described engaging trauma material through affective and somatic routes as well as direct memory work, which changes how you train therapists and how you plan integration to translate session material into durable behavior change.
OCD and migraine studies add promise, but also a warning about statistical power. In the first randomized, double-blind, placebo-controlled psilocybin trial for treatment-refractory OCD, an interpretative qualitative analysis (n=12) found that OCD symptoms can blunt or interfere with acute effects, yet participants still described post-dosing shifts that map onto established OCD therapy mechanisms. That implies a combined-care pathway: coordinate closely with OCD clinicians, and use integration to connect session insights to exposure and response prevention work rather than expecting a stand-alone effect.
For migraine prevention, a small double-blind trial (n=18) testing single or repeated “pulsed” psilocybin doses (10 mg) against an active placebo found large effect sizes but no statistically significant differences, with roughly 50% reductions in migraine frequency across eight weeks in all groups and partial blinding mimicry by diphenhydramine (the placebo). This is signal-finding science; clinics should not build migraine indications on it until larger trials settle effect size and protocol details.
Clinical and Policy Implications of December’s Psychedelic Research
The operational through-line is clear. First, design services in a manner that will be evaluated by payers and regulators: standardized dosing pathways, defined psychotherapy minutes, and routine outcomes collection that can support European HTA requirements and US coverage decisions. Esketamine’s real-world rollout remains the closest blueprint for this kind of infrastructure: in-clinic administration, observation, clear adverse-event reporting, and payment models that match the time burden on staff.
Second, translate these findings into clinical protocols now: compound-specific monitoring windows, therapist training that explicitly covers trauma engagement and compulsive symptom patterns, and scheduling models that account for preparation and integration as core clinical labor.
December’s data reinforce that progress will come from disciplined implementation in real systems, not from marketing claims. Delphi remains committed to a safe and equitable roll-out of psychedelic therapies grounded in evidence and workable care models.
