The future of mental health treatment is looking more psychedelic. A form of LSD has just shown the most promising findings yet for treating clinical depression.
On Monday morning, Definium Therapeutics announced the primary data from a Phase III trial testing its proprietary version of LSD, codenamed DT120. People with major depression taking a single dose of DT120 experienced a significantly greater reduction in their symptoms than those taking a placebo, the trial found. The company is planning to seek an expedited approval of its drug from the Food and Drug Administration.
“While I can’t speculate on what will happen post-approval, I can share that these results demonstrate unprecedented and highly differentiated efficacy and could potentially be practice-changing for many providers,” lead trial researcher John Sonnenberg, a clinical psychologist and faculty member at the Northwestern University Feinberg School of Medicine, told Gizmodo.
The biggest test of LSD for depression
LSD is short for lysergic acid diethylamide, though it’s also called lysergide. LSD is a semisynthetic drug derived from the ergot fungus and is well known for its psychedelic and hallucinogenic effects. It’s usually taken as an oral tablet, with its effects typically lasting between 6 and 12 hours, depending on the dosage.
Though LSD has long been enjoyed as a recreational drug for decades, it’s received (renewed) attention from scientists in recent years as a potential treatment for depression and other mental health conditions. Lab experiments and some small studies in people have suggested that LSD can promote new neural connections and cause other changes in the brain that reduce depressive symptoms quickly and for a sustained period of time. But the EMERGE trial from Definium (previously known as MindMed) was set up to be one of the biggest tests of this hypothesis to date.
The trial involved 149 participants across 20 sites, all of whom were diagnosed with major depressive disorder. For the first double-blinded phase of the trial, people were randomized to receive either a single 100-microgram dose of DT120 or a placebo; then they were monitored for 12 weeks.
According to the company, people taking DT120 on average experienced a noticeably larger reduction in their depression symptoms, based on a common scale used to measure depression. By the six-week mark, DT120 users overall saw an 8.1-point larger drop on this scale compared to the placebo group. About 35% of DT120 users had also substantially responded by week 6, meaning a reduction of 50% or more on the scale, compared to 7% of placebo users, while 12% experienced a remission (compared to 3% of the placebo group), meaning they no longer met the criteria for active depression. These improvements were slightly lessened but still apparent even by the 12-week mark.
The future of psychedelic medicine
These findings still have to be vetted by outside experts, an important part of the drug approval process. But assuming the data holds up, DT120 could represent a genuine game changer for depression, according to Sonnenberg, who is also the founder of the Uptown Research Institute.
“Many patients with depression aren’t helped by existing treatments, often experiencing partial responses, frequent medication changes, and long-term side effects,” he said. “DT120 could be a fundamentally different treatment option that may address several limitations of currently available treatments, particularly attractive for patients and providers seeking rapid and durable symptom relief from a single treatment administration, potentially reducing some of the challenges associated with chronic daily therapy.”
Definium is still awaiting the primary results of its second double-blinded, placebo-controlled Phase III trial of DT120 for depression, codenamed Ascend. Regulatory agencies typically require positive results from two major trials to approve a drug. Both trials also have an open extension phase, where people in either group can receive DT120 depending on their symptom severity. That said, the company is planning to seek breakthrough therapy designation from the FDA for DT120, a label intended to speed up a drug’s review and approval process.
“While any designation decision rests with the FDA, we believe the unprecedented efficacy profile and differentiated treatment characteristics demonstrated to date support consideration for BTD,” a spokesperson for Definium told Gizmodo.
The company is also developing DT120 for generalized anxiety disorder, with results from its Phase III trials expected to arrive later this year.
Read the full article here
