TL;DR
Get health and wellness essentials delivered free with Prime
- Fast, free delivery on millions of items
- Prime Video, Amazon Music and more included
- Member-only deals all year
Definium Therapeutics reported that DT120, an investigational orally disintegrating LSD tablet, met the primary endpoints in Phase III trials for generalized anxiety disorder and major depressive disorder. Trial results showed placebo-adjusted symptom improvements lasting through 12 weeks, but the findings have been presented at a medical congress and do not establish regulatory approval or long-term safety.
Definium Therapeutics reported that DT120, an investigational orally disintegrating tablet containing the psychedelic drug lysergide (LSD), met the primary endpoints in two Phase III trials for generalized anxiety disorder and major depressive disorder. The company said symptom reductions compared with placebo were seen within a week and remained measurable through week 12; the findings are trial results, not an approval for clinical use.
In the Voyage trial, 214 people with generalized anxiety disorder received either a single 100-microgram DT120 dose or placebo. At week 12, the DT120 group had an average 11.6-point reduction from baseline on the Hamilton Anxiety Rating Scale. The placebo-adjusted difference was 5.4 points (P<0.0001). A significant reduction was reported by week 1, when the change from baseline was 11.9 points and the difference versus placebo was 7.7 points.
In the Emerge trial, which enrolled 149 people with major depressive disorder, DT120 produced an 8.1-point placebo-adjusted improvement on the Montgomery-Åsberg Depression Rating Scale at week 6 (P<0.0001). The reported placebo-adjusted difference was 7.3 points at week 12 (P<0.0001). Both studies were presented at the Neuroscience Education Institute Fall Congress in Colorado Springs, Colorado. The source report identifies Dan Karlin, Definium’s chief medical officer, and colleagues as reporting the results.
Both trials involved a single supervised treatment session, rather than daily dosing. Average time to discharge clearance was 6.4 hours in Voyage and 5.8 hours in Emerge; participants in both studies were generally cleared within eight hours. The reported results include symptom-scale changes and response or remission rates, but do not establish how DT120 would perform in routine care or how its benefits and risks compare with established treatments over longer periods.
A Single Session, With Follow-Up
The results matter because they point to a possible treatment approach that differs from daily medication: one supervised dosing day followed by monitoring. In the trials, reductions in measured symptoms appeared early and persisted in group averages through the 12-week assessment period. That pattern could be relevant to patients and clinicians seeking alternatives, particularly because many participants had previously tried multiple medications.
However, the reported endpoints do not by themselves show that DT120 is more effective than available treatments, or that every patient would experience the same benefit. The treatment also required several hours of supervision on dosing day. Any future use would depend on the full evidence on benefits, risks, practical delivery and regulatory review—not symptom scores alone.
Products Worth Considering
Fitbit Sense 2 Health and Fitness Smartwatch, Shadow Grey/Graphite
Blueair Blue Pure 511i Max Smart Air Purifier
Therabody Mini 3rd Generation Massage Gun – Travel Essential (Black)
As an affiliate, we earn on qualifying purchases.
What the Two Trials Tested
Voyage enrolled people with substantial anxiety symptoms at baseline: the mean Hamilton Anxiety Rating Scale score was 27.9, and entry required a score of at least 20. More than a third of participants had tried two or more prior medications for anxiety. In Emerge, the average baseline depression score was 34.5 on the MADRS, with an entry threshold of 26; 53% of participants had previously received at least two antidepressants.
The trials also reported secondary outcomes. At week 12 in Voyage, 43% of DT120 recipients met the study’s anxiety-response threshold, compared with 16% on placebo; remission was reported for 14% and 4%, respectively. At week 6 in Emerge, response rates were 35% with DT120 and 7% with placebo, while remission rates were 24% and 3%. These are trial-specific results, and the two studies used different scales, populations and assessment time points.
“Seeing a clinically meaningful improvement in patients with this level and duration of disease gives us hope that DT120 could offer a new treatment option for people who have been suffering for years and are still in need of better outcomes.”
— Dan Karlin, Definium Therapeutics chief medical officer, speaking to MedPage Today
Safety and Approval Questions Remain
The available report does not provide full study protocols, detailed statistical analyses, or all trial data needed to independently assess the findings. The results were presented at a congress, and further details—including publication in a peer-reviewed journal—were not specified. It is also unclear from the report whether regulators have reviewed the data or what additional studies or filings may be required.
The company reported no serious adverse events in either study and no suicidal behavior or self-injurious behavior signals. Most reported adverse events were mild to moderate; commonly reported effects included illusions, euphoric mood and nausea on dosing day, with headache more common afterward. These trial observations do not settle uncommon risks, longer-term safety, or how outcomes may vary in broader patient populations. DT120 remains investigational.
Await Full Data and Regulatory Steps
Further reporting will depend on the release of fuller trial results and any subsequent peer-reviewed publication or regulatory updates from Definium Therapeutics. The supplied report does not give a timeline for a regulatory submission, a decision, or additional studies. Until those steps are described and completed, DT120 should be understood as an experimental treatment rather than an available alternative to approved anxiety or depression care.
Clinicians and patients will also need evidence addressing the duration of benefit, potential need for repeat dosing, safety beyond 12 weeks, and the staffing and monitoring required for supervised sessions. The current results establish that the trials met their stated primary endpoints; they do not answer those practical and clinical questions.
Key Questions
What is DT120?
DT120 is an investigational orally disintegrating tablet formulation of lysergide, also known as LSD. In the two reported Phase III trials, it was given as a single dose during a supervised session.
What did the Phase III trials find?
Definium reported that DT120 met the primary endpoints in the Voyage anxiety trial and the Emerge depression trial. The reported placebo-adjusted symptom improvements remained measurable through week 12.
How long did the reported benefits last?
The trial report describes group-level symptom improvements at assessments through week 12. It does not establish how long benefits last beyond that period or whether participants might need additional doses.
Is DT120 approved for anxiety or depression?
No approval is reported in the source material. DT120 remains an investigational treatment, and the trial results do not mean it is available for routine clinical use.
What side effects were reported?
The company reported that most adverse events were mild to moderate. Commonly reported events included illusions, euphoric mood and nausea on dosing day, and headache afterward. The trials do not resolve longer-term or uncommon risks.
Source: medpagetoday.com
